Osteochondritis DissecansNCT01458782
ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee
A study testing Treatment of cartilage defects in the knee in people with Osteochondritis Dissecans and Osteoarthritis, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of cartilage defects in the knee. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteochondritis Dissecans, Osteoarthritis, Cartilage Injury
- What is being tested?
- Treatment of cartilage defects in the knee
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2011to 30 Dec 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18-60 yrs
- informed consent signed by patient
- symptomatic cartilage defect in the knee > 2 square cm
Who cannot join
- alcohol or drug abuse during the last three yrs
- inflammatory joint disease
- serious illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing Autologous Chondrocyte Implantation Using Collagen Membrane (ACI-C) Versus (Autologous Matrix Induced Chondrogenesis) AMIC for Repair of Cartilage Defects in the Knee
ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of cartilage defects in the knee.
Eighty patients (Forty in each group) having symptomatic cartilage defects in their knee are planned to include in this study.
Read more
Both techniques will use the ChondroGide membrane from Geistlich to cover the defects. ACI includes an arthroscopy to harvest cartilage for cell cultivation in our lab located in Tromso. 3-4 weeks later using a mini arthrotomy the cells will be implanted under the ChondroGide membrane.
The AMIC group will be listed for a mini arthrotomy, cleaning of the defect, microfracture and cover of the defect using the same ChondroGide membrane.
In both groups stitches and fibrin glue will be used to fix the membrane.
Inclusion criteria:
Age between 18-60, Informed consent signed by patient, Symptomatic cartilage defect. Size more than 2 square cm.
Exclusion criteria Alcohol or drug abuse during the last three years, Inflammatory joint disease, Serious illness
Preoperative examination and follow up: Clinical examination and registration of KOOS (a validated knee score), VAS (visual analog pain scale) and Lysholm knee score. Radiographs of the involved knee including weightbearing standing radiographs of both knees. Kellgren- Lawrence classification will be used for grading of OA.
Patients will be checked after 1, 2, 5 and 10 years following surgery. Symptomatic patients having a new cartilage resurfacing operation or prosthesis will be listed as failures of the initial treatment.
Hypothesis: AMIC will be equal to ACI, and if that is the case this would be a benefit for the patients and the society. AMIC is much cheaper compared to ACI (needing an expensive cell cultivation and two surgeries).
Data will be analyzed using the SPSS statistical package.
Read the detailed description
Please see referenced articles (1-3) for details regarding ACI and AMIC
- Being tested
- Treatment of cartilage defects in the knee
- Keywords
- Cartilage repair, Chondrocytes, Stemcells
- Medical subject headings
- Osteochondritis Dissecans, Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of cartilage defects in the kneeProcedure or surgery
Also called Autologous chondrocyte implantation, Autologous matrix induced chondrogenesis
Two groups, either ACI or AMIC. ACI includes an arthroscopy for harvesting of cartilage 3-4 weeks prior to the open cartilage surgery. AMIC includes only open surgery at one setting.
| Study group | Role | What they receive |
|---|---|---|
| ACI-C | Active comparator | Autologous chondrocyte implantation using collagen membrane (ChondroGide) Please see reference 1 and 2 for details regarding ACI. In this study we are using the collagen membrane instead of periosteum- the other details are exactly the same as in our previous RCT. Receives: Procedure: Treatment of cartilage defects in the knee |
| AMIC | Active comparator | Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide).
Please see reference 3 for details regarding AMIC Receives: Procedure: Treatment of cartilage defects in the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Two Years.
KOOS is a knee-specific instrument, developed to assess the patients opinion about their knee and associated problems. It holds 42 items in 5 sub-scales (pain, other symptoms, function in daily living, function in sport and recreation and knee-related quality of life). The questionnaire yields a total score ranging from 0-100. A higher score indicates better knee function. The reported number is the mean change in KOOS total score from baseline after two years for each group. A positive number represents an improved knee function score.
Measured: 2-years follow-up.
Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Five Years.
KOOS is a knee-specific instrument, developed to assess the patients opinion about their knee and associated problems. It holds 42 items in 5 sub-scales (pain, other symptoms, function in daily living, function in sport and recreation and knee-related quality of life). The questionnaire yields a total score ranging from 0-100. A higher score indicates better knee function. The reported number is the mean change in KOOS total score from baseline after two years for each group. A positive number represents an improved knee function score.
Measured: 5-years follow-up
Secondary outcomes (7)
Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Two Years.
The Lysholm score is a scoring system for evaluating knee specific symptoms ranging from 0-100. Higher number indicates better knee function. The reported number is the mean change from baseline after two years for each group.
Measured: 2-years follow-up.
Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Two Years.
The VAS scores describes the patients pain on a scale (0-100). Lower numbers, means less pain. The reported number is the mean change from baseline after two years for each group. Higher numbers represent more relief of pain.
Measured: 2-years follow-up.
Failure
Treatment failures were reported as either a "hard failure" or a "clinical failure." A hard failure was defined as the patients needing a new resurfacing procedure of the index lesion or implantation of a knee prosthesis. A clinical failure was defined as any deterioration in KOOS scores at 2-year follow-up compared to baseline. Diagnostic re-arthroscopy or arthroscopy with debridement of synovia or the defect was not considered a failure. Sum of "hard" and "clinical" failures at two years in each group are reported.
Measured: 2-years follow-up
Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Five Years.
The Lysholm score is a scoring system for evaluating knee specific symptoms ranging from 0-100. Higher number indicates better knee function. The reported number is the mean change from baseline after five years for each group.
Measured: Five-year follow-up
Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Five Years
The VAS scores describes the patients pain on a scale (0-100). Lower numbers, means less pain. The reported number is the mean change from baseline after two years for each group. Higher numbers represent more relief of pain.
Measured: Five-years follow-up.
Failure
Treatment failures were reported as either a "hard failure" or a "clinical failure." A hard failure was defined as the patients needing a new resurfacing procedure of the index lesion or implantation of a knee prosthesis. A clinical failure was defined as any deterioration in KOOS scores at 5-year follow-up compared to baseline. Diagnostic re-arthroscopy or arthroscopy with debridement of synovia or the defect was not considered a failure. Sum of "hard" and "clinical" failures at two years in each group are reported.
Measured: 5-years follow-up
Kellgren-Lawrence Baseline vs 5-years in Each Group
Standing X-ray Rosenberg view of the knee obtained at baseline and 5-years follow up. X-rays were evaluated using the Kellgren-Lawrence scale by an independent orthopaedic surgeon.
Measured: 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completion15 Dec 2016
- Study completion30 Dec 2025 (estimated)
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 (4)Papers the sponsor has linked to this study.
- Other trials for Osteochondritis DissecansStudies 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
- RCT, Two arms ACI-C and AMIC
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
- Investigators
- Gunnar Knutsen, MD, PhD, Principal investigator, University Hospital of North NorwayAnn Kristin Hansen, MD, PhD, Study director, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458782
- Sponsor's protocol ID
- 2011/1159-3
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2011
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Knutsen G, Drogset JO, Engebretsen L, Grontvedt T, Isaksen V, Ludvigsen TC, Roberts S, Solheim E, Strand T, Johansen O. A randomized trial comparing autologous chondrocyte implantation with microfracture. Findings at five years. J Bone Joint Surg Am. 2007 Oct;89(10):2105-12. doi: 10.2106/JBJS.G.00003.
PubMed 17908884Knutsen G, Engebretsen L, Ludvigsen TC, Drogset JO, Grontvedt T, Solheim E, Strand T, Roberts S, Isaksen V, Johansen O. Autologous chondrocyte implantation compared with microfracture in the knee. A randomized trial. J Bone Joint Surg Am. 2004 Mar;86(3):455-64. doi: 10.2106/00004623-200403000-00001.
PubMed 14996869Benthien JP, Behrens P. The treatment of chondral and osteochondral defects of the knee with autologous matrix-induced chondrogenesis (AMIC): method description and recent developments. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1316-9. doi: 10.1007/s00167-010-1356-1. Epub 2011 Jan 14.
PubMed 21234543Fossum V, Hansen AK, Wilsgaard T, Knutsen G. Collagen-Covered Autologous Chondrocyte Implantation Versus Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee. Orthop J Sports Med. 2019 Sep 17;7(9):2325967119868212. doi: 10.1177/2325967119868212. eCollection 2019 Sep.
PubMed 31555714
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Autologous Chondrocyte Implantation Using Collagen Membrane (ACI-C) Versus (Autologous Matrix Induced Chondrogenesis) AMIC for Repair of Cartilage Defects in the Knee
- ClinicalTrials.gov ID
- NCT01458782
- Acronym / sponsor ID
- 2011/1159-3
- Keywords
- Cartilage repair, Chondrocytes, Stemcells
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Oct 2011 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of cartilage defects in the knee.
Eighty patients (Forty in each group) having symptomatic cartilage defects in their knee are planned to include in this study.
Both techniques will use the ChondroGide membrane from Geistlich to cover the defects. ACI includes an arthroscopy to harvest cartilage for cell cultivation in our lab located in Tromso. 3-4 weeks later using a mini arthrotomy the cells will be implanted under the ChondroGide membrane.
The AMIC group will be listed for a mini arthrotomy, cleaning of the defect, microfracture and cover of the defect using the same ChondroGide membrane.
In both groups stitches and fibrin glue will be used to fix the membrane.
Inclusion criteria:
Age between 18-60, Informed consent signed by patient, Symptomatic cartilage defect. Size more than 2 square cm.
Exclusion criteria Alcohol or drug abuse during the last three years, Inflammatory joint disease, Serious illness
Preoperative examination and follow up: Clinical examination and registration of KOOS (a validated knee score), VAS (visual analog pain scale) and Lysholm knee score. Radiographs of the involved knee including weightbearing standing radiographs of both knees. Kellgren- Lawrence classification will be used for grading of OA.
Patients will be checked after 1, 2, 5 and 10 years following surgery. Symptomatic patients having a new cartilage resurfacing operation or prosthesis will be listed as failures of the initial treatment.
Hypothesis: AMIC will be equal to ACI, and if that is the case this would be a benefit for the patients and the society. AMIC is much cheaper compared to ACI (needing an expensive cell cultivation and two surgeries).
Data will be analyzed using the SPSS statistical package.
Detailed description
Please see referenced articles (1-3) for details regarding ACI and AMIC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT, Two arms ACI-C and AMIC
| Arm | Type | Receives |
|---|---|---|
| ACI-C | Active comparator | Procedure: Treatment of cartilage defects in the kneeAutologous chondrocyte implantation using collagen membrane (ChondroGide) Please see reference 1 and 2 for details regarding ACI. In this study we are using the collagen membrane instead of periosteum- the other details are exactly the same as in our previous RCT. |
| AMIC | Active comparator | Procedure: Treatment of cartilage defects in the kneeAutologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18-60 yrs
- informed consent signed by patient
- symptomatic cartilage defect in the knee > 2 square cm
Key exclusion criteria (3 listed)
- alcohol or drug abuse during the last three yrs
- inflammatory joint disease
- serious illness
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 |
|---|---|---|
| Treatment of cartilage defects in the kneeAlso: Autologous chondrocyte implantation, Autologous matrix induced chondrogenesisTwo groups, either ACI or AMIC. ACI includes an arthroscopy for harvesting of cartilage 3-4 weeks prior to the open cartilage surgery. AMIC includes only open surgery at one setting. | Procedure or surgery | ACI-C, AMIC |
Primary outcome
Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Two Years.
Time frame: 2-years follow-up.
KOOS is a knee-specific instrument, developed to assess the patients opinion about their knee and associated problems. It holds 42 items in 5 sub-scales (pain, other symptoms, function in daily living, function in sport and recreation and knee-related quality of life). The questionnaire yields a total score ranging from 0-100. A higher score indicates better knee function. The reported number is the mean change in KOOS total score from baseline after two years for each group. A positive number represents an improved knee function score.
Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Five Years.
Time frame: 5-years follow-up
KOOS is a knee-specific instrument, developed to assess the patients opinion about their knee and associated problems. It holds 42 items in 5 sub-scales (pain, other symptoms, function in daily living, function in sport and recreation and knee-related quality of life). The questionnaire yields a total score ranging from 0-100. A higher score indicates better knee function. The reported number is the mean change in KOOS total score from baseline after two years for each group. A positive number represents an improved knee function score.
7 secondary outcomes
Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Two Years.
Time frame: 2-years follow-up.
Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Two Years.
Time frame: 2-years follow-up.
Failure
Time frame: 2-years follow-up
Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Five Years.
Time frame: Five-year follow-up
Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Five Years
Time frame: Five-years follow-up.
Failure
Time frame: 5-years follow-up
Kellgren-Lawrence Baseline vs 5-years in Each Group
Time frame: 5-year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17908884Knutsen G, Drogset JO, Engebretsen L, Grontvedt T, Isaksen V, Ludvigsen TC, Roberts S, Solheim E, Strand T, Johansen O. A randomized trial comparing autologous chondrocyte implantation with microfracture. Findings at five years. J Bone Joint Surg Am. 2007 Oct;89(10):2105-12. doi: 10.2106/JBJS.G.00003.
- Background: PubMed 14996869Knutsen G, Engebretsen L, Ludvigsen TC, Drogset JO, Grontvedt T, Solheim E, Strand T, Roberts S, Isaksen V, Johansen O. Autologous chondrocyte implantation compared with microfracture in the knee. A randomized trial. J Bone Joint Surg Am. 2004 Mar;86(3):455-64. doi: 10.2106/00004623-200403000-00001.
- Background: PubMed 21234543Benthien JP, Behrens P. The treatment of chondral and osteochondral defects of the knee with autologous matrix-induced chondrogenesis (AMIC): method description and recent developments. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1316-9. doi: 10.1007/s00167-010-1356-1. Epub 2011 Jan 14.
- Derived from this study: PubMed 31555714Fossum V, Hansen AK, Wilsgaard T, Knutsen G. Collagen-Covered Autologous Chondrocyte Implantation Versus Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee. Orthop J Sports Med. 2019 Sep 17;7(9):2325967119868212. doi: 10.1177/2325967119868212. eCollection 2019 Sep.
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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.
Gunnar Knutsen, MD, PhD principal investigator
University Hospital of North Norway
Ann Kristin Hansen, MD, PhD study director
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of cartilage defects in the knee in people with Osteochondritis Dissecans and Osteoarthritis, run by University Hospital of North Norway at 1 site in Norway.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 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 Norway. 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 17 Feb 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?
Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Two Years. (time frame: 2-years follow-up.). The study lists 2 primary outcomes in all. 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 NCT01458782, 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 17 Feb 2025.