Phase
Condition
Musculoskeletal Diseases
Treatment
BioPoly RS Partial Resurfacing Patella Implant
Clinical Study ID
Ages > 21 All Genders Accepts Healthy Volunteers
Study Summary
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
Study Description
Connect with a study center
Charing Cross Hospital
London, England W1G 6HL
United KingdomSite Not Available
Mid Yorkshire Hosp NHS
Wakefield, WF1 4DG
United KingdomSite Not Available
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