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interruption due to the ongoing corporate restructuring, which has resulted in the cessation of our interest in
pursuing any clinical activities related to the product.
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This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.
The patient-specific Bodycad Unicompartmental Knee System will be implanted on patients with knee osteoarthritis of the medial condyle. The study's hypothesis is that personalized shape and fit of patient-specific knee replacement prosthesis will provide a greater stability and a more natural knee motion in addition to a faster recovery when compared to traditional knee replacement systems. This study is designed to provide a five-years follow-up clinical data on safety and effectiveness of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Arthroplasty using BUKS | Experimental | Unicompartmental Knee Arthroplasty Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unicompartmental Knee Arthroplasty Surgery | Procedure | Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Knee Society Score (KSS) Objective | Assessment of improvement of clinical outcomes following BUKS implantation using the KSS questionnaire, to evaluate the clinical performance of the articulation | Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60 |
| Change from baseline in Knee Osteoarthritis Outcome Score (KOOS) | Assessment of improvement of activity levels following BUKS implantation surgery using the KOOS questionnaire | Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mechanical axis measurement. | Determine by radiographic analysis Varus or Valgus, expected value are +/- 3 degrees | Baseline and post operative week 1 |
| Change from baseline of implant position fixation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etienne Belzile, MD | CHU de Quebec - Hopital de l'Enfant-Jésus | Principal Investigator |
| Brian Hamlin, MD | Renaissance Orthopedics | Study Chair |
| Geoffroy Rivet-Sabourin, PhD | Laboratoires Bodycad Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Quebec - Universite Laval | Québec | G1J1Z4 | Canada |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Single group
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| Bodycad Unicompartmental Knee System (BUKS) | Device | Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS) |
|
The anteroposterior and medial lateral slop will be evaluated according to initial planed position. The measured angles will be compared with initial planning. The expected values are +/- 1.5 degree.
| Post operative week 6, months 6, 12, 24, 36, 48 and 60 |
| Change from baseline on bone loss and cementation | Those measurements will be done on x-ray of the patient joint following Knee Society Radiological evaluation form.The tibial component acceptable score for this device will be 2.5 mm. The femoral component acceptable score for this device will be 6 mm. | Post operative week 6, months 6, 12, 24, 36, 48 and 60 |
| D012216 |
| Rheumatic Diseases |