BioPoly® RS Partial Resurfacing Patella Registry Study

Completed

• Conditions: Cartilage Disease

• Registration Number: NCT02991300
• Lead Sponsor: BioPoly LLC

Brief Summary

The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring of the clinical safety and performance of the device and surgical implantation kit

Detailed Description

The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant This study will also allow monitoring of the clinical safety and performance of the device and surgical implantation kit

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-13
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Age 21 years and older
• Cartilage lesion(s) located in the facets of the patella that have failed prior therapy (conservative or surgical)
• Symptomatic lesions classified as ICRS grade 2, 3, or 4
• Lesion size may not exceed 3.1 cm2 and must be circumscribed by a 15 mm or 20 mm circle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall depth less than 4 mm from the articulating surface
• Subchondral bone quality sufficient to support the implant
• Understanding and willingness to comply with the post-operative rehabilitation instructions and follow-up visits.

Exclusion Criteria

• Body mass index (BMI) ≥ 35
• Generalized degenerative or autoimmune arthritis
• Gout
• Uncorrected chronic malalignment of the patella (may be corrected at the same time as the implantation of the BioPoly device).
• Uncorrected ligamentous instability (may be corrected at the same time as the implantation of the BioPoly device).
• Kissing lesion on femur
• More than one implant required to accommodate lesion
• Allergy to ultra-high molecular weight polyethylene (UHMWPE), or hyaluronan/ hyaluronic acid (HA)
• Use with opposing articulating femoral components
• Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
• Pregnant, prisoner, vulnerable population, or unable to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KOOS Subscores	2 year post-op	KOOS
Medical Outcomes Study (SF-36) for generic "quality of life"	2 years post-op	SF-36
Activity using Tegner Score	2 years post-op	Tegner
Kujala Anterior Knee Pain Scale	2 year post-op	Kujala
Pain using VAS Pain	2 years post-op	VAS Pain

Secondary Outcome Measures

Name	Time	Method
Radiographic Assessment	Annually through 5 years post-op	Radiographic Assessment

Trial Locations

Locations (2)

Charing Cross Hospital; 🇬🇧 London, England, United Kingdom

Mid Yorkshire Hosp NHS; 🇬🇧 Wakefield, United Kingdom