BioPoly® RS Partial Resurfacing Patella Registry Study

July 18, 2022 updated by: BioPoly LLC

Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Wakefield, United Kingdom, WF1 4DG
        • Recruiting
        • Mid Yorkshire Hosp NHS
        • Contact:
        • Principal Investigator:
          • James Newman, MD
    • England
      • London, England, United Kingdom, W1G 6HL
        • Recruiting
        • Charing Cross Hospital
        • Contact:
        • Principal Investigator:
          • Dinesh Nathwani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Assessment
Time Frame: Annually through 5 years post-op
Radiographic Assessment
Annually through 5 years post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioPoly LLC

Investigators

  • Principal Investigator: Dinesh Nathwani, MD, Charing Cross Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1251001 V2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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