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Trident® X3 Polyethylene Insert Study

Sponsored by Stryker Orthopaedics

About this trial

Last updated 7 years ago

Study ID

57

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
21 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status