Trident® X3 Polyethylene Insert Study
Sponsored by Stryker Orthopaedics
About this trial
Last updated 7 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 9 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. The patient has signed an IRB-approved, study specific Patient Informed Consent Form.
2. The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.
3. The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant.
4. The patient is a male or non-pregnant female patient ages 21 to 75.
5. The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria
1. The patient has an active infection with the affected hip joint.
2. The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
3. The patient has a BMI >45.
4. The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
5. The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
6. The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
7. The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
8. The patient is a prisoner.