Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, hip
Treatment trident® x3 polyethylene insert
Sponsor Stryker Orthopaedics
Start date May 2005
End date July 2012
Trial size 250 participants
Trial identifier NCT00958191, 57

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Participants who received the Trident® X3 Polyethylene Insert.
trident® x3 polyethylene insert
Trident® X3 Polyethylene Insert

Primary Outcomes

Measure
Mean Wear Rate in mm/Year
time frame: 5 years

Secondary Outcomes

Measure
Wear Rate & Volumetric Wear Rate
time frame: 5 years
Radiographic Stability
time frame: 5 years
Harris Hip Score (HHS)
time frame: 5 years
SF-12 Health Survey
time frame: 5 year
Lower Extremity Activity Scale
time frame: 5 years
Implant Survivorship
time frame: 10 years

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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.

Additional Information

Official title An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.
Principal investigator Benjamin Bierbaum, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Stryker Orthopaedics.