Cartilage or Osteochondral Defects in the KneeNCT03299959
Agili-C™ Implant Performance Evaluation
A study testing Agili-C implant and SSOC in people with Cartilage or Osteochondral Defects in the Knee and Up to Moderate Osteoarthritis, run by Smith & Nephew, Inc. at 26 sites in 8 countries.
Trial summary
The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cartilage or Osteochondral Defects in the Knee, Up to Moderate Osteoarthritis
- What is being tested?
- Agili-C implant and SSOC
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 26 sitesin 8 countries
- Study dates
- 25 Sep 2017to 14 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 -75 years
- Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea
- Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
- Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits
- Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable)
- Non-responsive to physical therapy for at least 3-4 weeks
Who cannot join
- KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)
- Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy
- Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above
- Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
- Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
- Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray
Show all 29Show fewer
- Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure
- Meniscal transplantation in the past 6 months
- Any known tumor of the index knee
- Any known history of intra-articular or osseous infection of the index knee
- Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other)
- Any known history of inflammatory arthropathy or crystal-deposition arthropathy
- Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
- Body Mass Index (BMI) > 35
- Chemotherapy in the past 12 months
- Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months
- Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months
- History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
- Patient who is pregnant or intends to become pregnant during the study
- History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies
- Known substance or alcohol abuse
- Participation in other clinical trials within 60 days prior to the study or concurrent with the study
- Known insulin dependent diabetes mellitus
- Unable to undergo either MRI or X-ray
- Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed
- Previous intra-articular steroid injection within the last 1 month
- Prisoners
- Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy
- Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
United States11 sites
Arlington Orthopedic Associates
Arlington, Texas, 76015
Brigham and Women's Hospital
Boston, Massachusetts, 02467
University of Missouri, Missouri Orthopaedic Institute
Columbia, Missouri, 65212
Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210
LSU Healthcare Network Orthopedic & Sports Medicine
New Orleans, Louisiana, 70112
NYU Langone Orthopedic Hospital
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Oregon Health & Science University
Portland, Oregon, 97239
OrthoVirginia
Richmond, Virginia, 23294
Peninsula Orthopaedic Associates
Salisbury, Maryland, 21804
Horizon Clinical Research
San Diego, California, 91942
Israel5 sites
Assaf Harofeh Medical Center
Be’er Ya‘aqov, 60930
"Carmel" Medical Center
Haifa, 3436212
Hadassah Medical Center
Jerusalem
Hasharon Hospital, Petach Tikva
Petah Tikva
Souraski Medical Center
Tel Aviv, 6423906
Serbia3 sites
Atlas General hospital
Belgrade
Clinic for Orthopedic Surgery "Banjica"
Belgrade
Clinical Center of Vojvodina
Novi Sad
Hungary2 sites
Uzsoki Utcai Kórház
Budapest, 1114
Kastélypark Klinika
Tata, 2892
About this study
Official title: A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee
The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.
Read the detailed description
This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions.
Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18, 24, 36, 48 and 60 months post-procedure to evaluate the patient's knee condition and clinical health.
The following questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation , SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18, 24, 36, 48 and 60 months.
Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 24, 36, 48 and 60 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months.
- Being tested
- Agili-C implant, SSOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agili-C implantDevice
Agili-C implant
SSOCProcedure or surgery
microfracture and/or debridement
| Study group | Role | What they receive |
|---|---|---|
| Agili-C | Experimental | Not described Receives: Device: Agili-C implant |
| Surgical Standard of Care (SSOC) | Active comparator | Not described Receives: Procedure: SSOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months
Change from Baseline to 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.
Measured: Baseline, 60 Months
Secondary outcomes (26)
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score consists of 9 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.
The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.
Measured: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score consists of 4 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.
The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.
Measured: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score consists of 17 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.
The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.
Measured: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score consists of 7 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.
The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.
Measured: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score consists of 5 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.
The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.
Measured: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score consists of 5 subscales. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Subscale scores are combined to produce the Overall Score that is transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome. Responder rate was defined as the proportion of participants achieving ≥30-point improvement from baseline to 60 months in the KOOS Overall Score.
The change from baseline data is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.
Measured: Baseline, 60 Months
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months
Change from Baseline to 36 Months and 48 months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, and 48 Months
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in the International Knee Documentation Committee (IKDC) Subjective Evaluation score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. The possible score ranges from 0 to 100, with a higher score indicating no limitation with daily or sporting activities and the absence of symptoms (i.e., a better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10, with a higher score indicating higher levels of activity (i.e., a better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Physical Component Score. The SF-12 Physical Component Score assesses health related quality of life. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Mental Component Score. The SF-12 Mental Component Score assesses mental health and well-being. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Chondral Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Osteochondral Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a Single Lesion measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Multiple Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Level of Osteoarthritis (Kellgren-Lawrence Grade 0-1): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Participants were categorized as without osteoarthritis based on Kellgren-Lawrence (K/L) grade of 0 to 1. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), and Grade 3 (Moderate).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Level of Osteoarthritis (Kellgren-Lawrence Grade 2-3): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Participants categorized with osteoarthritis based on Kellgren-Lawrence (K/L) grade of 2 to 3. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), or Grade 3 (Moderate).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area ≤3cm² measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area >3cm² measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants without previous ligament reconstruction was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with previous ligament reconstruction was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of intact meniscus (i.e., without a concomitant meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of previous partial meniscectomy (i.e., with a prior meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of concomitant partial meniscectomy (i.e., with a concomitant meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as active prior to injury (based on Tegner score) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as non-active prior to injury (based on Tegner score) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 36 Months, 48 Months, and 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start25 Sep 2017
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cartilage or Osteochondral Defects in the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizaveta Kon, MD, Principal investigator, Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299959
- Sponsor's protocol ID
- CLN0021
- Status last verified
- Nov 2024
- First submitted
- 14 Sep 2017
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kon E, De Caro F, Dasa V, M Scopp J, Di Matteo B, Flanigan D, Shabshin N, Strickland S, Altschuler N. Female patients report comparable results to males after the implantation of an aragonite-based scaffold for the treatment of knee chondral and osteochondral defects: a gender-based analysis of a RCT at 4 years' follow-up. J Orthop Traumatol. 2025 Mar 13;26(1):17. doi: 10.1186/s10195-025-00829-y.
PubMed 40080289Altschuler N, Zaslav KR, Di Matteo B, Sherman SL, Gomoll AH, Hacker SA, Verdonk P, Dulic O, Patrascu JM, Levy AS, Robinson D, Kon E. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Mar;51(4):957-967. doi: 10.1177/03635465231151252. Epub 2023 Feb 13.
PubMed 36779614
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee
- ClinicalTrials.gov ID
- NCT03299959
- Acronym / sponsor ID
- CLN0021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 5 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.
Detailed description
This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions.
Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18, 24, 36, 48 and 60 months post-procedure to evaluate the patient's knee condition and clinical health.
The following questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation , SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18, 24, 36, 48 and 60 months.
Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 24, 36, 48 and 60 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Agili-C | Experimental | Device: Agili-C implant |
| Surgical Standard of Care (SSOC) | Active comparator | Procedure: SSOC |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21 -75 years
- Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea
- Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
- Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits
- Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable)
Key exclusion criteria (29 listed)
- KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)
- Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy
- Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above
- Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
- Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agili-C implantAgili-C implant | Device | Agili-C |
| SSOCmicrofracture and/or debridement | Procedure or surgery | Surgical Standard of Care (SSOC) |
Primary outcome
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months
Time frame: Baseline, 60 Months
Change from Baseline to 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.
26 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months
Time frame: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months
Time frame: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months
Time frame: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months
Time frame: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months
Time frame: Baseline, 60 Months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months
Time frame: Baseline, 60 Months
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months
Time frame: Baseline, 36 Months, and 48 Months
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Level of Osteoarthritis (Kellgren-Lawrence Grade 0-1): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Level of Osteoarthritis (Kellgren-Lawrence Grade 2-3): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months
Time frame: Baseline, 36 Months, 48 Months, and 60 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40080289Kon E, De Caro F, Dasa V, M Scopp J, Di Matteo B, Flanigan D, Shabshin N, Strickland S, Altschuler N. Female patients report comparable results to males after the implantation of an aragonite-based scaffold for the treatment of knee chondral and osteochondral defects: a gender-based analysis of a RCT at 4 years' follow-up. J Orthop Traumatol. 2025 Mar 13;26(1):17. doi: 10.1186/s10195-025-00829-y.
- Derived from this study: PubMed 36779614Altschuler N, Zaslav KR, Di Matteo B, Sherman SL, Gomoll AH, Hacker SA, Verdonk P, Dulic O, Patrascu JM, Levy AS, Robinson D, Kon E. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Mar;51(4):957-967. doi: 10.1177/03635465231151252. Epub 2023 Feb 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizaveta Kon, MD principal investigator
Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agili-C implant and SSOC in people with Cartilage or Osteochondral Defects in the Knee and Up to Moderate Osteoarthritis, run by Smith & Nephew, Inc. at 26 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Israel, Serbia, Hungary, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months (time frame: Baseline, 60 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299959, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.