Cartilage DamageNCT04785092
All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects
A study testing All Autologous Cartilage Regeneration in people with Cartilage Damage and Cartilage Disease, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The cartilage articular defects of the knee are extremely disabling lesions and represent one of the predisposition causes to the development of articular arthrosis. When clinical symptoms are present, exist the indication to treat the patient surgically, to this end, several surgical techniques could be performed, as… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cartilage Damage, Cartilage Disease
- What is being tested?
- All Autologous Cartilage Regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Singular symptomatic chondral lesion classified as ICRS III or IV at the femoral condyle with less than 3 mm bone damage under the subchondral plate;
- Lesion between 1 and 8 cm2;
- BMI ≤ 34;
- Ability and will to actively participate in a strict rehabilitation protocol and follow-up.
Who cannot join
- Previous cartilage operation on the injured knee
- Additional grade III or IV lesion on the same knee
- Previous arthroscopic treatments that affect the AACR technique
- Ligamentous/patellofemoral instability/malposition, varus or valgus malposition ≤3° which cannot be treated/corrected simultaneously
- Previous tendon repair, ligament reconstruction or realignment within the last 6 months
- Any known human immunodeficiency virus, hepatitis, syphilis, malignancy or uncontrolled diabetes
Show all 12Show fewer
- Uncooperative patients who disregard or cannot follow instructions, including those who abuse drugs and/or alcohol
- Participation in a clinical drug or medical device trial that clinically interferes with the present observational study
- Inability to follow procedures (i.e. dementia)
- Inability to give consent
- No understanding of German language
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects: Pilot Study
The cartilage articular defects of the knee are extremely disabling lesions and represent one of the predisposition causes to the development of articular arthrosis.
When clinical symptoms are present, exist the indication to treat the patient surgically, to this end, several surgical techniques could be performed, as the microfractures, osteochondral transplantation (OCT) or chondrocytes autologous transplantation (ACT).
Read more
The aim of this pilot study is to evaluate the clinical performance of a modified version of the ACT technique, the All Autologous Cartilage Repair technique (AACR). A one-step technique in which the healthy cartilage harvested is fragmented directly in situ and then mixed with the autologous platelet concentrate and directly injected in the cartilage defect.. This lead to a less invasive surgery and cost-effective procedure.
The performance will be evaluated through the evaluation of clinical results and complications after surgery other than the evaluation of the quality of the cartilage tissue repaired.
Read the detailed description
The aim of the Pilot Study is to describe the clinical performance of the AACR technique in the treatment of the cartilage defects in terms of complications after surgery, quality of the repaired cartilage tissue and clinical results with regard to pain and function of the treated knee.
The quality of the repaired cartilage tissue will be evaluate through MRI and clinical outcomes by the Patient Reported Outcome Measures (PROMs).
All patients will undergo to a blood sample (used to product the patient's own platelet concentrate) and an arthroscopic procedure to debride degenerated cartilage tissue and to the harvesting of the surrounding healthy cartilage. The fragmented healthy cartilage will mixed with the platelet concentrate (PC) and injected directly into the cartilage defect to fill it. The platelet concentrate stimulates the healing of the cartilage most actively.
Before and after surgical treatment all patient will undergo to a follow-up visits after 6, 12 and 24 months. MRI will be performed at pre-surgery visit and at the 12 and 24 follow-up visits.
- Conditions
- Cartilage Damage, Cartilage Disease
- Being tested
- All Autologous Cartilage Regeneration
- Keywords
- cartilage, cartilage defect, articular cartilage repair, All Autologous Cartilage Repair, Autologous Chondrocyte Transplantation
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All Autologous Cartilage RegenerationProcedure or surgery
Also called Autologous cartilage transplantation
All patients will undergo firstly to a blood sampling and then to the arthroscopic debridement of the damage cartilage and subsequently will be harvested the surrounding healthy cartilage The harvested and healthy cartilage will shredded directly in situ with a shaver. This cartilage will then mixed with the patient's own Platelet Concentrate and may be injected directly into the cartilage defect. The Platelet Concentrate stimulates the healing of the cartilage most effectively. At the same time, the Platelet Concentrate will also used to produce autologous fibrin glue, which can be used to fix the applied cartilage chip / Platelet Concentrate product quickly and safely in the damaged cartilage.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - All Autologous Cartilage Regeneration | Experimental | Not described Receives: Procedure: All Autologous Cartilage Regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee functionality assessed by KOOS
The primary clinical outcome is the change in knee functionality assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire over 2 years (before treatment, at baseline, versus 6, 12 and 24 months postoperative). The KOOS is a Patient Reported Outcome Measure (PROM) designed to asses patient-relevant outcomes following knee injury.
It is a self-completion questionnaire with a 1-week-recall-period with 42 items and 5 subscales (pain, symptoms, activities of daily life, sport and leisure, quality of life associated with the knee joint). Each question has five answering options, scored with a numerical value of 0 - 4. In average, it takes 10 minutes to complete. The calculation of the respective sub-score is done by adding up the marked items of the relevant subscales. These numerical values are then converted into a scale value between 0 (extreme knee problems) and 100 (free of knee joint complaints).
Measured: (before treatment, 6, 12 and 24 months postoperative
Secondary outcomes (5)
Quality of cartilage repair tissue MRI evaluation
The quality of cartilage repair tissue will be assessed with the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART). The MOCART score is the variable of primary interest because it allows both the evaluation of cartilage repair tissue and the surrounding structures. The MOCART score is based on nine variables measured on a standard MRI and added up to a score, ranging from 0 to 100, where 100 represents the best score and a score of 0 represents the worst score.
Measured: 12 and 24 months
Difference between baseline and follow-up visits of the physical examination
The physical examination will evaluate the knee swelling, dynamic and static alignment.
Measured: Baseline, 6, 12 and 24 months
Marx activity rating scale (MARS)
is patient-administered and takes only 1 minute to complete. It includes 4 items that assess the frequency of running, cutting, decelerating, and pivoting based on the subjects "healthiest and most active state in the past year." Each question has five answering options, scored with a numerical value of 0 - 4. The score of all items is summed up for the total score, which ranges from 0 (lowest physical or sporting activity) to 16 (highest physical or sporting activity).
Measured: Baseline, 6, 12 and 24 months
Numeric Rating Scale (NRS) for pain
is a single item question about the average pain on ordinary days with average physical activity, where numerical answers are anchored by 0 (no pain) and 10 (worst possible pain)
Measured: Baseline, 6, 12 and 24 months
Baseline quality of cartilage repair tissue MRI evaluation
The AMADEUS (Area Measurement And DEpth \& Underlying Structures) scoring system includes the three most important different parameters that describe a focal chondral or osteochondral defect prior to possible cartilage repair surgery: (1) the cartilage defect area, which is measured ("area measurement"); (2) the cartilage defect morphology/depth ("depth"); and (3) the underlying structures with presence of adjacent osseous defects/subchondral cysts and bone marrow edema-like lesions (BME) ("under- lying structures"). In addition to the resulting AMADEUS code, sub-scores were defined for each feature, which sum up to a total score of 100 (no osteochondral defect) to 0 (worst score).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Mar 2021
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cartilage DamageStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785092
- Sponsor's protocol ID
- AACR
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2021
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Na Y, Shi Y, Liu W, Jia Y, Kong L, Zhang T, Han C, Ren Y. Is implantation of autologous chondrocytes superior to microfracture for articular-cartilage defects of the knee? A systematic review of 5-year follow-up data. Int J Surg. 2019 Aug;68:56-62. doi: 10.1016/j.ijsu.2019.06.007. Epub 2019 Jun 18.
PubMed 31220632Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L. Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N Engl J Med. 1994 Oct 6;331(14):889-95. doi: 10.1056/NEJM199410063311401.
PubMed 8078550Massen FK, Inauen CR, Harder LP, Runer A, Preiss S, Salzmann GM. One-Step Autologous Minced Cartilage Procedure for the Treatment of Knee Joint Chondral and Osteochondral Lesions: A Series of 27 Patients With 2-Year Follow-up. Orthop J Sports Med. 2019 Jun 13;7(6):2325967119853773. doi: 10.1177/2325967119853773. eCollection 2019 Jun.
PubMed 31223628Brittberg M, Peterson L, Sjogren-Jansson E, Tallheden T, Lindahl A. Articular cartilage engineering with autologous chondrocyte transplantation. A review of recent developments. J Bone Joint Surg Am. 2003;85-A Suppl 3:109-15. doi: 10.2106/00004623-200300003-00017. No abstract available.
PubMed 12925617
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects: Pilot Study
- ClinicalTrials.gov ID
- NCT04785092
- Acronym / sponsor ID
- AACR
- Conditions
- Cartilage Damage, Cartilage Disease
- Keywords
- cartilage, cartilage defect, articular cartilage repair, All Autologous Cartilage Repair, Autologous Chondrocyte Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cartilage articular defects of the knee are extremely disabling lesions and represent one of the predisposition causes to the development of articular arthrosis.
When clinical symptoms are present, exist the indication to treat the patient surgically, to this end, several surgical techniques could be performed, as the microfractures, osteochondral transplantation (OCT) or chondrocytes autologous transplantation (ACT).
The aim of this pilot study is to evaluate the clinical performance of a modified version of the ACT technique, the All Autologous Cartilage Repair technique (AACR). A one-step technique in which the healthy cartilage harvested is fragmented directly in situ and then mixed with the autologous platelet concentrate and directly injected in the cartilage defect.. This lead to a less invasive surgery and cost-effective procedure.
The performance will be evaluated through the evaluation of clinical results and complications after surgery other than the evaluation of the quality of the cartilage tissue repaired.
Detailed description
The aim of the Pilot Study is to describe the clinical performance of the AACR technique in the treatment of the cartilage defects in terms of complications after surgery, quality of the repaired cartilage tissue and clinical results with regard to pain and function of the treated knee.
The quality of the repaired cartilage tissue will be evaluate through MRI and clinical outcomes by the Patient Reported Outcome Measures (PROMs).
All patients will undergo to a blood sample (used to product the patient's own platelet concentrate) and an arthroscopic procedure to debride degenerated cartilage tissue and to the harvesting of the surrounding healthy cartilage. The fragmented healthy cartilage will mixed with the platelet concentrate (PC) and injected directly into the cartilage defect to fill it. The platelet concentrate stimulates the healing of the cartilage most actively.
Before and after surgical treatment all patient will undergo to a follow-up visits after 6, 12 and 24 months. MRI will be performed at pre-surgery visit and at the 12 and 24 follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment - All Autologous Cartilage Regeneration | Experimental | Procedure: All Autologous Cartilage Regeneration |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singular symptomatic chondral lesion classified as ICRS III or IV at the femoral condyle with less than 3 mm bone damage under the subchondral plate;
- Lesion between 1 and 8 cm2;
- BMI ≤ 34;
- Ability and will to actively participate in a strict rehabilitation protocol and follow-up.
Key exclusion criteria (12 listed)
- Previous cartilage operation on the injured knee
- Additional grade III or IV lesion on the same knee
- Previous arthroscopic treatments that affect the AACR technique
- Ligamentous/patellofemoral instability/malposition, varus or valgus malposition ≤3° which cannot be treated/corrected simultaneously
- Previous tendon repair, ligament reconstruction or realignment within the last 6 months
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 |
|---|---|---|
| All Autologous Cartilage RegenerationAlso: Autologous cartilage transplantationAll patients will undergo firstly to a blood sampling and then to the arthroscopic debridement of the damage cartilage and subsequently will be harvested the surrounding healthy cartilage The harvested and healthy cartilage will shredded directly in situ with a shaver. This cartilage will then mixed with the patient's own Platelet Concentrate and may be injected directly into the cartilage defect. The Platelet Concentrate stimulates the healing of the cartilage most effectively. At the same time, the Platelet Concentrate will also used to produce autologous fibrin glue, which can be used to fix the applied cartilage chip / Platelet Concentrate product quickly and safely in the damaged cartilage. | Procedure or surgery | Treatment - All Autologous Cartilage Regeneration |
Primary outcome
Change in knee functionality assessed by KOOS
Time frame: (before treatment, 6, 12 and 24 months postoperative
The primary clinical outcome is the change in knee functionality assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire over 2 years (before treatment, at baseline, versus 6, 12 and 24 months postoperative). The KOOS is a Patient Reported Outcome Measure (PROM) designed to asses patient-relevant outcomes following knee injury. It is a self-completion questionnaire with a 1-week-recall-period with 42 items and 5 subscales (pain, symptoms, activities of daily life, sport and leisure, quality of life associated with the knee joint). Each question has five answering options, scored with a numerical value of 0 - 4. In average, it takes 10 minutes to complete. The calculation of the respective sub-score is done by adding up the marked items of the relevant subscales. These numerical values are then converted into a scale value between 0 (extreme knee problems) and 100 (free of knee joint complaints).
5 secondary outcomes
Quality of cartilage repair tissue MRI evaluation
Time frame: 12 and 24 months
Difference between baseline and follow-up visits of the physical examination
Time frame: Baseline, 6, 12 and 24 months
Marx activity rating scale (MARS)
Time frame: Baseline, 6, 12 and 24 months
Numeric Rating Scale (NRS) for pain
Time frame: Baseline, 6, 12 and 24 months
Baseline quality of cartilage repair tissue MRI evaluation
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 31220632Na Y, Shi Y, Liu W, Jia Y, Kong L, Zhang T, Han C, Ren Y. Is implantation of autologous chondrocytes superior to microfracture for articular-cartilage defects of the knee? A systematic review of 5-year follow-up data. Int J Surg. 2019 Aug;68:56-62. doi: 10.1016/j.ijsu.2019.06.007. Epub 2019 Jun 18.
- Background: PubMed 8078550Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L. Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N Engl J Med. 1994 Oct 6;331(14):889-95. doi: 10.1056/NEJM199410063311401.
- Background: PubMed 31223628Massen FK, Inauen CR, Harder LP, Runer A, Preiss S, Salzmann GM. One-Step Autologous Minced Cartilage Procedure for the Treatment of Knee Joint Chondral and Osteochondral Lesions: A Series of 27 Patients With 2-Year Follow-up. Orthop J Sports Med. 2019 Jun 13;7(6):2325967119853773. doi: 10.1177/2325967119853773. eCollection 2019 Jun.
- Background: PubMed 12925617Brittberg M, Peterson L, Sjogren-Jansson E, Tallheden T, Lindahl A. Articular cartilage engineering with autologous chondrocyte transplantation. A review of recent developments. J Bone Joint Surg Am. 2003;85-A Suppl 3:109-15. doi: 10.2106/00004623-200300003-00017. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Cartilage Damage
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect
Active, not recruiting
Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage
Osteoarthritis, Knee Pain Arthritis
Recruiting
This is a Study to Evaluate Nanofractures Technique in the Treatment of Cartilage Lesions
Cartilage Damage
RecruitingPhase 4
Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems
Knee Osteoarthristis, Cartilage Damage
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All Autologous Cartilage Regeneration in people with Cartilage Damage and Cartilage Disease, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 4 inclusion and 12 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in knee functionality assessed by KOOS (time frame: (before treatment, 6, 12 and 24 months postoperative). 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 NCT04785092, which also lists 4 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 6 Mar 2025.