N/A
N=128
Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee
Articular Cartilage Defects
Bottom Line
View on ClinicalTrials.gov: NCT01251588 ↗Enrolled (actual)
128
Serious AEs
25.8%
Results posted
Apr 2017
Primary outcome: Primary: Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational Activities) Scores. — 42.14; 35.77; 45.63; 36.95 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- autologous cultured chondrocytes on porcine collagen membrane (Biological); Microfracture (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vericel Corporation
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational Activities) Scores. |
42.14; 35.77; 45.63; 36.95 | — |
| SECONDARY Change From MACI00206 Baseline for the Participant's KOOS Pain and Function (Sports and Recreational Activities) Scores |
45.17; 38.42; 47.17; 37.56 | — |
| SECONDARY Magnetic Resonance Imaging (MRI) Assessments of Degree of Defect Fill |
44; 39 | — |
| SECONDARY Proportion of Patients Who Achieve at Least a 10-point Improvement From MACI00206 Baseline in KOOS Pain and Function (Sports and Recreational Activities) Scores |
51; 46 | — |
| SECONDARY The Proportion of Patients in Each Treatment Group Assessed as Treatment Failures |
1; 1 | — |
| SECONDARY Average Time to Treatment Failure |
1; 1 | — |
| SECONDARY Change From MACI00206 Baseline in the Remaining 3 Subscales (Activities of Daily Living, Quality of Life, and Other Symptoms) of KOOS |
42.82; 35.86; 39.9; 34.53; 32.53; 28.45 | — |
| SECONDARY Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form |
35.48; 31.58 | — |
| SECONDARY Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the Modified Cincinnati Knee Rating System |
3.55; 2.71 | — |
| SECONDARY Change From MACI00206 Baseline in the 12-Item Short-Form Health Survey (SF-12) Physical and Mental Component Scores |
1.52; 1.28; 0.38; 0.52 | — |
| SECONDARY Change From MACI00206 Baseline in the European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Score |
20.14; 17.1 | — |
| SECONDARY Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) |
49; 47 | — |
| SECONDARY Number of Participants Reporting Serious Adverse Events (SAEs) |
16; 17 | — |
| SECONDARY Number of Participants Having Subsequent Surgical Procedures (SSPs) in Target Knee |
7; 6 | — |
Summary
To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the knee.
Eligibility Criteria
Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.
Data sourced from ClinicalTrials.gov (NCT01251588). 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.