A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Hip Arthroplasty
- Sponsor
- Midwest Orthopaedics at Rush
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Does the Trident II Cup achieve acceptable fixation to the underlying bone?
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.
Detailed Description
The proposed study is a prospective evaluation of data from patients undergoing primary total hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for this study. All patients that qualify for the study per the inclusion-exclusion criteria and provide written informed consent will receive the Trident II acetabular cup and RSA beads. Implant stability, through RSA, will be measured throughout the first two postoperative (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6 months, 1 year, and 2 years following surgery. Patients will be discharged and seen for follow-up assessments as per standard of care. Adverse events that are related to the index joint will be collected. Health outcome questionnaires will be collected. The health outcome questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery. Conventional x-ray analysis will be performed pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptomatic arthritis of the hip indicating surgical intervention
- •Scheduled to undergo a primary total hip arthroplasty
- •Patient is a candidate for the Trident II acetabular cup in accordance with product labeling -
Exclusion Criteria
- •Patients less than 18 years of age, or older than 85 years of age.
- •Severe hip dysplasia (Crowe Type III or IV) in the affected hip
- •History of congenital dislocation
- •Prior arthroplasty of the affected hip
- •Active or prior infection of the affected hip
- •Morbid obesity (BMI \> 40)
- •Medical condition precluding major surgery
- •Severe osteoporosis
- •Neuromuscular impairment
- •Patients with known allergy to metals
Outcomes
Primary Outcomes
Does the Trident II Cup achieve acceptable fixation to the underlying bone?
Time Frame: 3 years
The Trident II Cup proximal migration will be assessed. Migration of less than 0.2mm at 2 years and without continuous migration between post-operative year 1 and 2 will indicate acceptable fixation.
Secondary Outcomes
- What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?(3 years)
- Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?(3 years)
- Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?(3 years)
- Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?(2 years)