Collagen-Covered Autologous Chondrocyte Implantation Versus Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee

Vegard Fossum, Ann Kristin Hansen, Tom Wilsgaard, Gunnar Knutsen, Vegard Fossum, Ann Kristin Hansen, Tom Wilsgaard, Gunnar Knutsen

Abstract

Background: Autologous matrix-induced chondrogenesis (AMIC) is a single-stage alternative to autologous chondrocyte implantation for treatment of localized cartilage defects of the knee. To our knowledge, no randomized controlled trial exists comparing the 2 methods.

Purpose: To evaluate any difference in the outcome of AMIC as compared with collagen-covered autologous chondrocyte implantation (ACI-C).

Study design: Randomized controlled trial; Level of evidence, 2.

Methods: A prospective randomized controlled clinical trial was designed to assess any differences in the outcomes between ACI-C and AMIC for the treatment of ≥1 chondral or osteochondral defects of the distal femur and/or patella. The inclusion period was set to 3 years, and the aim was to include 80 patients (40 in each group). Patient inclusion was broad, with few exclusion criteria. The primary outcome was change in Knee injury and Osteoarthritis Outcome Score (KOOS) at 2 years as compared with baseline. The secondary outcomes were the number of failures in each group at 2 years and the change in KOOS subscale, Lysholm, and pain visual analog scale (VAS) scores at 2 years as compared with baseline. A 2-sample t test with a significance level of P < .05 was used to compare the change in score from baseline between groups.

Results: A total of 41 patients over 3 years were included in the study: 21 in the ACI-C group and 20 in the AMIC group. All the patients had prior surgery to the index knee. At 2-year follow-up, the clinical scores for both groups improved significantly from baseline. No significant differences between groups were seen in the change from baseline for KOOS (AMIC, 18.1; ACI-C, 10.3), any of the KOOS subscales, the Lysholm score (AMIC, 19.7; ACI-C, 17.0), or the VAS pain score (AMIC, 30.6; ACI-C, 19.6). Two patients in the AMIC group had progressed to a total knee replacement by the 2-year follow-up as compared with none in the ACI-C group.

Conclusion: At 2-year follow-up, no significant differences were found regarding outcomes between ACI-C and AMIC. Mid- and long-term results will be important.

Registration: NCT01458782 (ClinicalTrials.gov identifier).

Keywords: ACI-C; AMIC; autologous chondrocyte implantation; autologous matrix-induced chondrogenesis; cartilage repair; clinical outcome; knee.

Conflict of interest statement

The authors declared that there are no conflicts of interest in the authorship and publication of this contribution. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.

Figures

Figure 1.
Figure 1.
Trial progression flowchart. ACI-C, collagen-covered autologous chondrocyte implantation; AMIC, autologous matrix-induced chondrogenesis.
Figure 2.
Figure 2.
Mean KOOS score at baseline and follow-up for both intention-to-treat populations. Mean delta KOOS was significantly higher than zero at 1 year: 9.7 (P = .02) in the ACI-C group and 15.0 (P = .002) in the AMIC group. Mean delta KOOS was significantly higher than zero at 2 years: 10.3 (P = .008) in the ACI-C group and 18.1 (P = .001) in the AMIC group. Error bars represent 95% CIs. ACI-C, collagen-covered autologous chondrocyte implantation; AMIC, autologous matrix-induced chondrogenesis; KOOS, Knee injury and Osteoarthritis Outcome Score.
Figure 3.
Figure 3.
Mean Lysholm score at baseline and follow-up for both intention-to-treat populations. Mean delta Lysholm score was significantly higher than zero at 1 year: 12.0 (P = .004) in the ACI-C group and 16.7 (P < .001) in the AMIC group. Mean delta Lysholm score was significantly higher than zero at 2 years: 17.0 (P < .001) in the ACI-C group and 19.7 (P = .001) in the AMIC group. Error bars represent 95% CIs. ACI-C, collagen-covered autologous chondrocyte implantation; AMIC, autologous matrix-induced chondrogenesis.
Figure 4.
Figure 4.
Mean VAS pain score at baseline and follow-up for both intention-to-treat populations. Mean delta VAS was significantly higher than zero at 1 year: 22.8 (P < .001) in the ACI-C group and 28.2 (P < .001) in the AMIC group. Mean delta VAS was significantly higher than zero at 2 years: 19.6 (P = .002) in the ACI-C group and 30.6 (P < .001) in the AMIC group. Error bars represent 95% CIs. ACI-C, collagen-covered autologous chondrocyte implantation; AMIC, autologous matrix-induced chondrogenesis; VAS, visual analog scale.
Figure 5.
Figure 5.
Comparison of mean delta for KOOS subscores in each group at 2 years. Error bars represent 95% CIs. ADL, activities of daily living; KOOS, Knee injury and Osteoarthritis Outcome Score; QOL, quality of life; Sym, Symptoms.
Figure 6.
Figure 6.
The mean with 95% CI for the difference between the groups in delta KOOS for the per-protocol (PP) and intention-to-treat (ITT) populations at 2 years. If the 95% CI were located entirely to the right of zero, AMIC would have been proven superior. If it were located entirely to the left of zero, ACI-C would have been proven superior. For both populations, the 95% CI crossed zero, meaning no superiority was proven. The lowest noninferiority margin (–3.45) for statistically proven noninferiority of AMIC as compared with ACI-C is shown as the vertical dotted line. ACI-C, collagen-covered autologous chondrocyte implantation; AMIC, autologous matrix-induced chondrogenesis; KOOS, Knee injury and Osteoarthritis Outcome Score.
Figure 7.
Figure 7.
Mean delta KOOS at 2 years in patients with and without previous microfracture to the index knee, P = .79. Error bars indicate 95% CI. KOOS, Knee injury and Osteoarthritis Outcome Score.

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Source: PubMed

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