Trident® X3 Polyethylene Insert Study

Completed · Not applicable

Conditions studied: Arthroplasty, Replacement, Hip

In brief

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 measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.

Key facts

Study ID

NCT00958191

Run by

Stryker Orthopaedics

People needed

250

Starts

2005-05-01

Expected to finish

2016-12-01

Last updated by the study team

2018-02-23

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States
• Bonutti Research Inc. — Effingham, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• New England Baptist Hospital — Boston, Massachusetts, United States
• J. Wesley Mesko, MD — Lansing, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Good Samaritan Hospital — Kearney, Nebraska, United States
• Greater Pittsburgh Orthopaedics Assoc — Pittsburgh, Pennsylvania, United States
• University of Vermont College of Medicine — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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