Study of the HemiCAP™ Unicondylar Femoral Resurfacing Prosthesis."
|Study Design:||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."|
- 20% or greater improvement in WOMAC score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- No secondary surgical intervention related to a device-related adverse event occurred [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Stable implant (no subsidence, loosening or radiolucency) on radiographic evaluation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- SF36 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- WOMAC [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- physical examination [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Study Completion Date:||November 2013|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: HemiCAP resurfacing
insertion of a focal thermocondyl resurfacing device for inlay athroplasty
Device: HemiCAP Resurfacing
intraoperative joint surface mapping and implantation of patient specific, matching inlay resurfacing prosthetic
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158444
|Fowler Kennedy Sport Medicine Clinic|
|London, Ontario, Canada, N6A 3K7|
|Principal Investigator:||Robert B Litchfield, MD, FRCSC||Fowler Kennedy Sport Medicine Clinic|