BioPoly® RS Partial Resurfacing Patella Registry Study

NCT02991300 | Completed

• 1 other identifier: 1251001 V2.0
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

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

Conditions

Cartilage Disease

Keywords

focal defect; focal lesion; chondral lesion; osteochondral lesion

Outcome Measures

Primary Outcomes (5)

• KOOS Subscores

  KOOS

  2 year post-op

• Kujala Anterior Knee Pain Scale

  Kujala

  2 year post-op

• Medical Outcomes Study (SF-36) for generic "quality of life"

  SF-36

  2 years post-op

• Activity using Tegner Score

  Tegner

  2 years post-op

• Pain using VAS Pain

  VAS Pain

  2 years post-op

Secondary Outcomes (1)

• Radiographic Assessment

  Annually through 5 years post-op

Interventions

BioPoly RS Partial Resurfacing Patella Implant DEVICE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population who will participate in this clinical study includes those patients 21 years of age or older who otherwise meet the inclusion/exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioPoly LLC: lead

Study Sites (2)

Charing Cross Hospital

London, England, W1G 6HL, United Kingdom

Location

Mid Yorkshire Hosp NHS

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dinesh Nathwani, MD

  Charing Cross Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 13, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)