Phase 3
N=144
Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
Articular Cartilage Defect
Bottom Line
View on ClinicalTrials.gov: NCT00719576 ↗Enrolled (actual)
144
Serious AEs
20.8%
Results posted
Dec 2017
Primary outcome: Primary: Change From Baseline to Week 104 for the Participant's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational Activities) Scores. — 45.45; 35.23; 46.04; 35.83 units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- autologous cultured chondrocytes on porcine collagen membrane (Biological); Microfracture (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vericel Corporation
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 104 for the Participant's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational Activities) Scores. |
45.45; 35.23; 46.04; 35.83 | 0.001 sig |
| SECONDARY Histological Evaluation of Structural Repair of Evaluable Biopsies Harvested From the Core of the Index Lesion During Arthroscopy at Week 104 |
63.8; 62.3 | .717 |
| SECONDARY Assessment of Defect Fill by Magnetic Resonance Imaging (MRI) |
58; 53 | .920 |
| SECONDARY Response Rate Based on KOOS Pain and Function (Sports and Recreational Activities) Scores at Week 104. |
63; 49 | 0.016 sig |
| SECONDARY Treatment Failure |
0; 2 | — |
| SECONDARY Change From Baseline at Week 104 in the Remaining 3 Subscales of the KOOS Instrument (Activities of Daily Living, Knee-related Quality of Life, and Other Symptoms) |
43.70; 32.76; 37.41; 29.93; 35.47; 27.31 | <0.001 sig |
| SECONDARY Participants With Treatment-Emergent Adverse Events |
55; 60 | — |
Summary
The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.
Eligibility Criteria
Inclusion Criteria
- Symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement
Exclusion Criteria
- Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
- Severe osteoarthritis of the knee
- Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders
- Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.
Data sourced from ClinicalTrials.gov (NCT00719576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.