Trident® X3 Polyethylene Insert Study

Stryker Orthopaedics250 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Arthroplasty, Replacement, Hip

Interventions

Trident® X3 Polyethylene InsertDEVICE

Trident® X3 Polyethylene Insert

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (9)

Emory University

Atlanta, Georgia, United States

Bonutti Research Inc.

Effingham, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

New England Baptist Hospital

Outcomes

Primary Outcomes

Mean Linear Wear Rate at 5 Years

Time frame: 5 years

Rate of Incidence of Revision of Component for Any Reason

Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.

Time frame: 5 year

Secondary Outcomes

Linear Wear Rate of the Trident X3 Polyethylene Insert

Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.

Time frame: 2, 3 and 4 year films collected; 3 and 4 year wear assessed

Volumetric Wear Rate of the Trident X3 Polyethylene Insert

Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.

Data from ClinicalTrials.gov

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