Trident® X3 Polyethylene Insert Study

Stryker

Status: Completed

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: Trident® X3 Polyethylene Insert

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958191

57

Details and patient eligibility

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.

Full 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 being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.

Enrollment: 250 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Trident® X3 Polyethylene Insert

Other group

Description:

Participants who received the Trident® X3 Polyethylene Insert.

Treatment:

Device: Trident® X3 Polyethylene Insert