A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Episealer® Knee System Compared to Microfracture for the Treatment of Focal Femoral Knee Chondral or Osteochondral Lesions
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Lesion of Articular Cartilage of Knee
- Sponsor
- Episurf Medical Inc.
- Enrollment
- 13
- Locations
- 13
- Primary Endpoint
- Incidence of subsidence or migration at 24 months
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The study is a randomized, prospective, multicenter, controlled clinical trial of the Episealer Knee System. The Episealer Knee System is intended for subjects with up to two focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment.
Detailed Description
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Episealer Knee System (Episealer Trochlea Solo, Episealer Femoral Twin, and Episealer Condyle Solo) compared to microfracture (with or without debridement) in a group of subjects that require repair of up to 2 focal femoral chondral or osteochondral lesions in the knee. Clinical success will be analyzed via subject reported outcomes to measure function and pain improvements as compared to baseline, incidence of secondary surgical interventions for the treated knee, absence of subsidence or migration through radiographic assessment, and assessment of weight-bearing status.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of subsidence or migration at 24 months
Time Frame: 24 Months
This endpoint will examine the incidence of subsidence/migration at 24 months
Incidence of Secondary Surgical Intervention
Time Frame: 24 Months
This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months
Change in Visual Analog Scale (VAS) Pain Scores
Time Frame: 24 Months
This endpoint will examine the change in VAS Pain scores at 24 months
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores
Time Frame: 24 Months
This endpoint will examine the change in KOOS subscores at 24 months
Weight bearing status
Time Frame: 8 weeks
This endpoint will examine the weight bearing status at 8 weeks
Secondary Outcomes
- Change in 12-Item Short Form Survey (SF-12) score at all follow-up time points(3-weeks, 8-weeks, 6-months, 12-months, and 24-months)
- Change in VAS Pain score at all follow-up time points(3-weeks, 8-weeks, 6-months, 12-months, and 24-months)
- Incidence of adverse events and device deficiencies at all follow-up time points(3-weeks, 8-weeks, 6-months, 12-months and 24-months)
- Incidence of radiographic findings at all follow-up time points(8 weeks, 12-months, and 24-months)
- Change in the KOOS Subscores at all follow-up time points(3-weeks, 8-weeks, 6-months, 12-months, and 24-months)