Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Zimmer Biomet
- Enrollment
- 332
- Locations
- 6
- Primary Endpoint
- Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.
Detailed Description
Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant. This study is an extension of the surgeons' data collection as an attempt from Zimmer-Biomet to fulfill its post-market surveillance obligations by recovering clinical data retrospectively and prospectively. Study Procedure Flowchart - retrospective data collection: most patients had clinical follow-ups at pre-op, operative, immediate post-op, 3 Months, 1 year, 2, 3, 5, 7 years post-surgery during which their surgeons collected clinical data. This data will therefore only be collected by Zimmer-Biomet after the patients specifically consent to it. Study Procedure Flowchart - prospective data collection: The informed consent signed by the patient for this study also allow Zimmer Biomet to collect the data of the standard clinical follow-up that will be conducted by the investigators at least 10 years post-surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time Frame: 10 years post-surgery
Secondary Outcomes
- Safety based on eventual complications occurred including dislocations and revisions/removals(10 years post-surgery])
- Subject quality-of-life determined by the EQ-5D (EuroQoI) score(10 years post-surgery)
- Pain and functional performance based on the Harris Hip Score(10 years post-surgery)
- X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc(10 years post-surgery)