BioPoly® RS Partial Resurfacing Patella Registry Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
Body mass index (BMI) ≥ 35
Generalized degenerative or autoimmune arthritis
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.