Clinical trial NCT01458782: ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteochondritis Dissecans
Osteoarthritis
Cartilage Injury
Osteonecrosis
Keywords: Cartilage repair
Chondrocytes
Stemcells
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2011-10-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT, Two arms ACI-C and AMIC
Primary purpose: TREATMENT

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.

Detailed description: Please see referenced articles (1-3) for details regarding ACI and AMIC

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Two Years.
timeFrame: 2-years follow-up.
measure: Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Five Years.
timeFrame: 5-years follow-up
Secondary outcomes:
measure: Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Two Years.
timeFrame: 2-years follow-up.
measure: Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Two Years.
timeFrame: 2-years follow-up.
measure: Failure
timeFrame: 2-years follow-up
measure: Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Five Years.
timeFrame: Five-year follow-up
measure: Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Five Years
timeFrame: Five-years follow-up.
measure: Failure
timeFrame: 5-years follow-up
measure: Kellgren-Lawrence Baseline vs 5-years in Each Group
timeFrame: 5-year follow-up
Other outcomes:
Locations:
city: Tromso
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Gunnar Knutsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway
name: Ann Kristin Hansen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.