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Marketing, Clinical Trials for Wright Hip Resurfacing System
Here are parts of the FDA's premarket approval letter dated November 2009 for the Conserve Plus Total Resurfacing Hip System made by Wright Medical Technology, Inc.
The CONSERVE® Plus Total Resurfacing Hip System is a single use device intended for hybrid fixation utilizing cemented femoral head component and cement-less acetabular component.
The CONSERVE® Plus Total Resurfacing Hip System is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
--Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip
Or --Inflammatory arthritis such as rheumatoid arthritis.
The CONSERVE® Plus Total Resurfacing Hip System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future hip joint revision.
The letter goes on to say that approval is granted but conditions follow such as agreeing to two post approval studies:
Long-term use: This study is designed to evaluate the longer term safety and effectiveness of the CONSERVE Plus Total Resurfacing Hip System. Specific study questions to be answered are:
- (1) What is the longer-term safety performance of the CONSERVE Plus Total Resurfacing Hip System?
- (2) What is the longer-term effectiveness performance of the CONSERVE Plus Total Resurfacing Hip System?
New enrollment study: This study is designed to examine the performance of the CONSERVE Plus Total Resurfacing Hip System in newly enrolled patients under real world conditions of use. The specific question to be answered is:
What is the performance of the CONSERVE Plus Total Hip Resurfacing system under actual use conditions?
Currently, the clinical trial is seeking patients who have already undergone hip resurfacing in the CONSERVE Plus IDE. The estimated completion date is November 2015.
Patients who already suffer from serious Conserve Hip Resurfacing side effects don’t need a clinical trial; they need legal intervention.