BioPoly® RS Partial Resurfacing Patella Registry Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02991300

Enrollment

Registered

2016-12-13

Start date

2016-09-30

Completion date

2024-12-31

Last updated

2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Disease

Keywords

focal defect, focal lesion, chondral lesion, osteochondral lesion

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

Interventions

DEVICEBioPoly RS Partial Resurfacing Patella Implant

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
KOOS Subscores	2 year post-op	KOOS
Kujala Anterior Knee Pain Scale	2 year post-op	Kujala
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
Pain using VAS Pain	2 years post-op	VAS Pain

Secondary

Measure	Time frame	Description
Radiographic Assessment	Annually through 5 years post-op	Radiographic Assessment

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026