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CompletedNCT02991300Updated Apr 16, 2025

BioPoly® RS Partial Resurfacing Patella Registry Study

An observational study in Cartilage Disease, sponsored by BioPoly LLC. Completed at 2 sites in United Kingdom. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by BioPoly LLC · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
12
Ages
21 Years and older
Sex
All
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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

Read the 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

02

Conditions studied

  • Cartilage Disease

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Keywords

  • focal defect
  • focal lesion
  • chondral lesion
  • osteochondral lesion
03

In context

Cartilage Diseases

73 studies on the registry are indexed under Cartilage Diseases; 5 are open to participants now.

This study's planned enrollment of 12 is below the median of 80 across 19 observational studies indexed under Cartilage Diseases.

Browse Cartilage Diseases studies →

Lead sponsor

BioPoly LLC is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Other
Enrollment
12 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • DeviceBioPoly RS Partial Resurfacing Patella Implant
06

What researchers measure

Primary outcomes

  1. KOOS Subscores

    KOOS

    Time frame: 2 year post-op

  2. Kujala Anterior Knee Pain Scale

    Kujala

    Time frame: 2 year post-op

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

    SF-36

    Time frame: 2 years post-op

  4. Activity using Tegner Score

    Tegner

    Time frame: 2 years post-op

  5. Pain using VAS Pain

    VAS Pain

    Time frame: 2 years post-op

Secondary outcomes

  1. Radiographic Assessment

    Radiographic Assessment

    Time frame: Annually through 5 years post-op

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Study locations

2 sites
  • Charing Cross Hospital
    London, England W1G 6HL, United Kingdom
  • Mid Yorkshire Hosp NHS
    Wakefield, WF1 4DG, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02991300
Lead sponsor
BioPoly LLC
Responsible party
Sponsor
First posted
Dec 13, 2016
Start date
Sep 2016
Primary completion
Dec 2024
Completion
Dec 2024
Last update
Apr 16, 2025

Study contacts

Dinesh Nathwani, MD
principal investigator · Charing Cross Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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