Trial Outcomes & Findings for ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee (NCT NCT01458782)

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

2-years follow-up.

Results posted on

2025-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	ACI-C 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. 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.	AMIC Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC 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.
Overall Study STARTED	21	20
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACI-C n=21 Participants 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. 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.	AMIC n=20 Participants Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC 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.	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=21 Participants	0 Participants n=20 Participants	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=21 Participants	20 Participants n=20 Participants	41 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants	0 Participants n=20 Participants	0 Participants n=41 Participants
Age, Continuous	37 years STANDARD_DEVIATION 10.8 • n=21 Participants	38 years STANDARD_DEVIATION 8.2 • n=20 Participants	37.5 years STANDARD_DEVIATION 9.1 • n=41 Participants
Sex: Female, Male Female	7 Participants n=21 Participants	12 Participants n=20 Participants	19 Participants n=41 Participants
Sex: Female, Male Male	14 Participants n=21 Participants	8 Participants n=20 Participants	22 Participants n=41 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Norway	21 participants n=21 Participants	20 participants n=20 Participants	41 participants n=41 Participants

PRIMARY outcome

Timeframe: 2-years follow-up.

Population: Comparison between groups were performed on the intention-to-treat population (ITT)

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.

Outcome measures

Outcome measures
Measure	ACI-C n=21 Participants 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. 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.	AMIC n=20 Participants Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC 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.
Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Two Years.	10.3 score on a scale Standard Deviation 16.0	18.1 score on a scale Standard Deviation 19.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-years follow-up.

Population: Comparison between groups were performed on the intention-to-treat population (ITT).

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.

Outcome measures

Outcome measures
Measure	ACI-C n=21 Participants 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. 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.	AMIC n=20 Participants Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC 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.
Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Two Years.	17.0 score on a scale Standard Deviation 14.9	19.7 score on a scale Standard Deviation 22.9

SECONDARY outcome

Timeframe: 2-years follow-up.

Population: Intention to treat population (ITT)

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.

Outcome measures

Outcome measures
Measure	ACI-C n=21 Participants 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. 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.	AMIC n=20 Participants Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC 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.
Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Two Years.	19.6 units on a scale Standard Deviation 25.9	30.6 units on a scale Standard Deviation 26.0

SECONDARY outcome

Timeframe: 2-years follow-up

Population: Intention to treat population (ITT)

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.

Outcome measures

Outcome measures
Measure	ACI-C n=21 Participants 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. 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.	AMIC n=20 Participants Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC 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.
Failure	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Five-year follow-up

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Five-years follow-up.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5-years follow-up

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5-year follow-up

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.

Outcome measures

Outcome data not reported

Adverse Events

ACI-C

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

AMIC

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ACI-C n=21 participants at risk 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. 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.	AMIC n=20 participants at risk Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC 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.
Musculoskeletal and connective tissue disorders Re-arthroscopy within 2 years	14.3% 3/21 • Number of events 4 • 2 years reported. 5 years will be reported later. No dedicated reporting system for adverse events, but the patients were followed up in such a manner that adverse events like death, surgical complications and re-operations would be reported.	15.0% 3/20 • Number of events 4 • 2 years reported. 5 years will be reported later. No dedicated reporting system for adverse events, but the patients were followed up in such a manner that adverse events like death, surgical complications and re-operations would be reported.

Additional Information

Dr.Ann Kristin Hansen

University Hospital North Norway

Phone: +4777669763

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place