Study of the HemiCAP™ Unicondylar Femoral Resurfacing Prosthesis."
Recruitment status was Active, not recruiting
Patients with large unstable Grade IV articular surface defects, with significant subchondral bone exposure and who will likely receive a joint replacement will receive the HemiCAP™ Femoral Resurfacing Prosthesis. The Subject Device intends to offer a surgical alternative to these patients who might otherwise endure years of pain and loss of function while awaiting a more appropriate age for joint replacement surgery.
Procedure: insertion of the HemiCAP™ Femoral Resurfacing Prosthesis
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||"A Prospective, Non-Randomized, Non-Comparative, Open Label Multi-Center, Feasibility Study to Examine the Safety and Effectiveness of the HemiCAP™ Unicondylar Femoral Resurfacing Prosthesis."|
- Effectiveness:The Self-Reported Patient Pain scores will be reported for the baseline and 24-month assessments.
- Reoperation rate
- Patient disposition
- Radiograph data
- Operative procedures/findings
- Concomitant medications
- Adverse events
- Post-operative recovery and length of hospital stay data
- Patient Grade, Swelling, Giving-Way, and Locking
- Activities of Daily Living, Functional Scores
- Occupational Rating Scores
- Secondary Effectiveness determination improvement in the Cincinnati Knee Rating System:
- Physician Exam; flexion, extension, quadriceps strength
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||December 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
The objective of the proposed clinical investigation is to determine safety and effectiveness of the investigational device in the management of pain and restoration of joint function as part of an interim clinical treatment strategy.
This is a pivotal, prospective, non-randomized, non-comparative, open label clinical study, to evaluate the safety and effectiveness of the HemiCAP™ Femoral Resurfacing Prosthesis.
The study will involve up to 15 qualified investigational sites.
Patients who meet the inclusion/exclusion criteria will be consented by the coordinator for the study at the centre and receive a baseline evaluation and knee exam. Standard radiographs will be taken and the subject will fill out quality of life questionnaires. The surgical procedure will take place within 1 month of the baseline evaluation.
Follow-up evaluations will occur at 2 weeks, 6 weeks and 3 months following the surgery. At these evaluations, radiographs will be taken and the patient will fill out a post-op progress and satisfaction assessment forms. Any concomitant medications and adverse events will be documented. In addition at 6, 12 and 24 months following the surgery, the patients will fill out the quality of life questionnaires.
|Fowler Kennedy Sport Medicine Clinic|
|London, Ontario, Canada, N6A 3K7|
|Principal Investigator:||Robert B Litchfield, MD, FRCSC||Fowler Kennedy Sport Medicine Clinic|