An interventional study of Treatment of cartilage defects in the knee in Osteochondritis Dissecans, Osteoarthritis and Cartilage Injury, sponsored by University Hospital of North Norway. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Treatment
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.
Please see referenced articles (1-3) for details regarding ACI and AMIC
30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.
This study's enrollment of 41 is close to the median of 45 across 17 interventional studies indexed under Osteochondritis Dissecans.
Browse Osteochondritis Dissecans studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Treatment of cartilage defects in the knee
Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC
Procedure: Treatment of cartilage defects in the knee
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.
Also known as: Autologous chondrocyte implantation, Autologous matrix induced chondrogenesis
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.
Time frame: 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.
Time frame: 5-years follow-up
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.
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.
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 5-year follow-up
| Milestone | ACI-C | AMIC |
|---|---|---|
| Started | 21 | 20 |
| Completed | 21 | 20 |
| Not completed | 0 | 0 |
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.
| score on a scale | ACI-C | AMIC |
|---|---|---|
| Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Two Years. | 10.3 ± 16.0 | 18.1 ± 19.4 |
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.
Results for this outcome have not been posted.
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.
| score on a scale | ACI-C | AMIC |
|---|---|---|
| Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Two Years. | 17.0 ± 14.9 | 19.7 ± 22.9 |
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.
| units on a scale | ACI-C | AMIC |
|---|---|---|
| Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Two Years. | 19.6 ± 25.9 | 30.6 ± 26.0 |
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.
| Participants | ACI-C | AMIC |
|---|---|---|
| Failure | 3 | 5 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 2 years reported. 5 years will be reported later.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ACI-C | 0/21 (0%) | 0/21 (0%) | 3/21 (14.3%) |
| AMIC | 0/20 (0%) | 0/20 (0%) | 3/20 (15%) |
| Event | ACI-C | AMIC |
|---|---|---|
| Re-arthroscopy within 2 yearsMusculoskeletal and connective tissue disorders | 3/21 | 3/20 |
| Age, Categorical(Participants) | ACI-C | AMIC | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 20 | 41 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | ACI-C | AMIC | Total |
|---|---|---|---|
| Mean | 37 ± 10.8 | 38 ± 8.2 | 37.5 ± 9.1 |
| Sex: Female, Male(Participants) | ACI-C | AMIC | Total |
|---|---|---|---|
| Female | 7 | 12 | 19 |
| Male | 14 | 8 | 22 |
| Race and Ethnicity Not Collected(Participants) | ACI-C | AMIC | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | ACI-C | AMIC | Total |
|---|---|---|---|
| Norway | 21 | 20 | 41 |
Ran from Oct 2011 to primary completion in Dec 2016, 62 months.
Results were first posted in Feb 2025, 8 years 2 months after primary completion.
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