BioPoly® RS Partial Resurfacing Patella Registry Study

Last updated: April 15, 2025
Sponsor: BioPoly LLC
Overall Status: Completed

Phase

N/A

Condition

Musculoskeletal Diseases

Treatment

BioPoly RS Partial Resurfacing Patella Implant

Clinical Study ID

NCT02991300
1251001 V2.0
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 21 years and older

  • Cartilage lesion(s) located in the facets of the patella that have failed priortherapy (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 mmcircle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overalldepth 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 rehabilitationinstructions and follow-up visits.

Exclusion

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 timeas the implantation of the BioPoly device).

  • Uncorrected ligamentous instability (may be corrected at the same time as theimplantation 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 thatwould interfere with evaluation of the afflicted knee

  • Pregnant, prisoner, vulnerable population, or unable to provide informed consent.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: BioPoly RS Partial Resurfacing Patella Implant
Phase:
Study Start date:
September 01, 2016
Estimated Completion Date:
December 31, 2024

Study 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

Connect with a study center

  • Charing Cross Hospital

    London, England W1G 6HL
    United Kingdom

    Site Not Available

  • Mid Yorkshire Hosp NHS

    Wakefield, WF1 4DG
    United Kingdom

    Site Not Available

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