BioPoly® RS Partial Resurfacing Patella Registry Study
United Kingdom12 participantsStarted 2016-09
Plain-language 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
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
KOOS Subscores
Timeframe: 2 year post-op
2
Kujala Anterior Knee Pain Scale
Timeframe: 2 year post-op
3
Medical Outcomes Study (SF-36) for generic "quality of life"