Status:
COMPLETED
Trident® X3 Polyethylene Insert Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This ...
Detailed Description
The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is...
Eligibility Criteria
Inclusion
- The patient has signed an IRB-approved, study specific Patient Informed Consent Form.
- The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.
- 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.
- The patient is a male or non-pregnant female patient ages 21 to 75.
- The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion
- The patient has an active infection with the affected hip joint.
- The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- The patient has a BMI \>45.
- The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
- The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
- The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
- The patient is a prisoner.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00958191
Start Date
May 1 2005
End Date
December 1 2016
Last Update
February 23 2018
Active Locations (9)
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1
Emory University
Atlanta, Georgia, United States, 30329
2
Bonutti Research Inc.
Effingham, Illinois, United States, 62401
3
Indiana University
Indianapolis, Indiana, United States, 46202-5111
4
New England Baptist Hospital
Boston, Massachusetts, United States, 02120