Degenerative Lesion of Articular Cartilage of Knee
Conditions
Keywords
Knee, Cartilage
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.
Interventions
DEVICEEpisealer Knee System
The Episealer Knee System is comprised of individualized endoprosthetic resurfacing implants and implantation tools (Episealer Toolkit). The implants are designed to replace the articulating surface which has been damaged due to femoral knee chondral and osteochondral defects.
PROCEDUREMicrofracture
Microfracture is a minimally invasive surgical technique developed to repair defects in articular cartilage and reduce pain in the knee joint. Microfracture techniques are described in the orthopedic literature and are performed arthroscopically.
Sponsors
MCRA
Episurf Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
In this investigation, neither the investigator nor the subject can be blinded to the treatment group assignment due to the implant's distinctive form that can be detected on radiographs; however, the randomization assignment will not be disclosed to the subject until after surgery is performed.
Intervention model description
A total of 180 subjects will be enrolled and randomized using a 2:1 ratio (Episealer: Microfracture). Within each site, subjects will be randomized into one of the two study arms using a blocked randomization scheme with varying block sizes.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Be ≥ 30 years and ≤ 70 years. 2. Have up to 2 symptomatic femoral chondral or osteochondral defects in the index knee on the medial or lateral femoral condyles or the knee trochlea area, which are: 1. ICRS Grade 2, 3 or Grade 4 2. Each suitable for treatment with 1 Episealer device NOTE: Additional femoral cartilage lesions which, in the opinion of the investigator, are asymptomatic and free from underlying bone lesions (e.g., bone edema) will not be treated. 3. Have focal articular defect(s) each with a cartilage lesion area ≥ 1.5 cm2 and ≤ 7.0 cm2. 1. Subjects with up to two defects ≥ 1.5 cm2 and ≤ 4.0 cm2, that are surrounded by adequate circumferential cartilage as determined by the investigator, will be randomized. 2. Subjects with at least one defect \> 4.0 cm2 and ≤ 7.0 cm2, with adequate bony support as determined by the investigator, will not be randomized, and will receive the Episealer device. 4. Have screening scores that meet the following criteria: 1. Visual Analog Scale (VAS) pain score of the index knee of ≥ 40 mm 2. KOOS Overall Score of ≤ 60 5. Have experienced knee pain symptoms and undergone prior non-surgical management (e.g., physical therapy, bracing, HA injections) for at least 4 weeks prior to being considered for the study. 6. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study. 7. Be willing and able to comply with all study procedures including all pre-operative, post-operative, and rehabilitation requirements. If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant in the next 24 months.
Exclusion criteria
Pre-Operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight bearing status | 8 weeks | This endpoint will examine the weight bearing status at 8 weeks |
| Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores | 24 Months | This endpoint will examine the change in KOOS subscores at 24 months |
| Change in Visual Analog Scale (VAS) Pain Scores | 24 Months | This endpoint will examine the change in VAS Pain scores at 24 months |
| Incidence of Secondary Surgical Intervention | 24 Months | This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months |
| Incidence of subsidence or migration at 24 months | 24 Months | This endpoint will examine the incidence of subsidence/migration at 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the KOOS Subscores at all follow-up time points | 3-weeks, 8-weeks, 6-months, 12-months, and 24-months | This endpoint will examine the change in KOOS subscores at all follow-up time points |
| Change in VAS Pain score at all follow-up time points | 3-weeks, 8-weeks, 6-months, 12-months, and 24-months | This endpoint will examine the change in VAS Pain scores at all follow-up time points |
| 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 | This endpoint will examine the change in SF-12 scores at all follow-up time points |
| Incidence of radiographic findings at all follow-up time points | 8 weeks, 12-months, and 24-months | This endpoint will examine the incidence of radiographic findings at all follow-up time points |
| Incidence of adverse events and device deficiencies at all follow-up time points | 3-weeks, 8-weeks, 6-months, 12-months and 24-months | This endpoint will examine the safety via the incidence of adverse events and device deficiencies at all follow-up time points |
Countries
Canada, Germany, United Kingdom, United States
Outcome results
None listed