ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee

NCT01458782 | Active Not Recruiting Results

• 1 other identifier: 2011/1159-3
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteochondritis Dissecans; Osteoarthritis; Cartilage Injury; Osteonecrosis

Keywords

Cartilage repair; Chondrocytes; Stemcells

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5-years follow-up

Secondary Outcomes (7)

• Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Two Years.

  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.

  2-years follow-up.

• Failure

  2-years follow-up

• Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Five Years.

  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

  Five-years follow-up.

Study Arms (2)

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.

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

Procedure: Treatment of cartilage defects in the knee

Interventions

Treatment of cartilage defects in the knee PROCEDURE

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

ACI-C; AMIC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18-60 yrs
• informed consent signed by patient
• symptomatic cartilage defect in the knee \> 2 square cm

You may not qualify if:

• alcohol or drug abuse during the last three yrs
• inflammatory joint disease
• serious illness

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Related Publications (4)

• 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.

  PMID: 17908884 BACKGROUND

• Knutsen 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.

  PMID: 14996869 BACKGROUND

• Benthien 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.

  PMID: 21234543 BACKGROUND

• Fossum 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.

  PMID: 31555714 DERIVED

MeSH Terms

Conditions

Osteochondritis Dissecans; Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr.Ann Kristin Hansen
• Organization: University Hospital North Norway

ann.kristin.hansen@unn.no

+4777669763

Study Officials

• Gunnar Knutsen, MD, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

• Ann Kristin Hansen, MD, PhD

  University Hospital of North Norway

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT, Two arms ACI-C and AMIC

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2011
• Primary Completion: December 15, 2016
• Study Completion: December 30, 2025
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Locations

NO (1)