Interventional procedure overview of focal resurfacing implants to treat articular cartilage damage in the knee
Closed for comments This consultation ended on at Request commenting lead permission
Additional information considered by IPAC
Professional experts' opinions
Expert advice was sought from consultants who have been nominated or ratified by their professional Society or Royal College. The advice received is their individual opinion and is not intended to represent the view of the society. The advice provided by professional experts, in the form of the completed questionnaires, is normally published in full on the NICE website during public consultation, except in circumstances but not limited to, where comments are considered voluminous, or publication would be unlawful or inappropriate.
Two Professional expert questionnaires for focal articular resurfacing implants for treating articular cartilage defects in the knee were submitted and can be found on the NICE website.
Patient commentators' opinions
NICE's Public Involvement Programme sent questionnaires to NHS trusts for distribution to patients who had the procedure (or their carers). NICE received 7 completed questionnaires.
The patient commentators' views on the procedure were consistent with the published evidence and the opinions of the professional experts.
Company engagement
A structured information request was sent to 3 companies who manufacture a potentially relevant device for use in this procedure. NICE received 2 completed submissions. These were considered by the IP team and any relevant points have been taken into consideration when preparing this overview.
Issues for consideration by IPAC
The following are ongoing studies for the BioPoly and Episealer implants:
NCT01473199: BioPoly RS Knee Registry Study for Cartilage Defect Replacement. Multicentre, open label, prospective, consecutive series registry database. Single group, n=38 people with focal cartilage defects of the femoral condyles treated with the BioPoly RS partial resurfacing knee implant; primary outcome: change in KOOS at 6 months and 2 years; location UK; study completion date December 2021. Status Active, not recruiting.
NCT02991300: BioPoly RS partial resurfacing patellofemoral registry study; open label, prospective, consecutive series registry database of BioPoly RS partial resurfacing patellofemoral implant. Single group, n=35 people with focal cartilage defects of the patellofemoral compartment. Primary outcomes: KOOS sub-scores, Kujala anterior knee pain scale, quality of life (SF-36), activity using Tegner score, pain using VAS score. Planned follow up: 5 years, location UK; completion date September 2026. Status Recruiting.
NCT04000659: Episealer Knee System IDE Clinical Study. Randomized (2:1), prospective, multicentre, controlled trial of the Episealer Knee System for patients with a focal femoral knee chondral or osteochondral lesion. Episealer knee system compared to microfracture (with or without debridement). Two groups, n=180 people, primary outcome: KOOS sub-scores, VAS pain scores, incidence of secondary surgical intervention, subsidence or migration at 24 months, and weight bearing status at 8 weeks; location UK, US, Denmark, Germany; estimated completion date June 2022. Status Recruiting.
NCT03755388: Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant. Long-term prospective interventional clinical trial of an MRI based patient specific focal knee resurfacing implant - Episealer 2 Study. Single group, n=30 people. Primary outcome is 10-year survival of the Episealer implant. Location Belgium; estimated completion date December 2032. Status recruiting.
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions