Trident® X3 Polyethylene Insert Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958191
• Other study ID #: 57
• Status: Completed
• Phase: N/A
• First received: August 11, 2009
• Last updated: January 26, 2018
• Start date: May 2005
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2016
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Trident® X3 Polyethylene Insert
Trident® X3 Polyethylene Insert

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Linear Wear Rate at 5 Years	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 of 5 years	5 years
Primary	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.	5 year
Secondary	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.	2, 3 and 4 year films collected; 3 and 4 year wear assessed
Secondary	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.	2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed
Secondary	Radiographic Stability	Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.	1,2,3,4 and 5 years
Secondary	Mean Harris Hip Score (HHS) to Assess Change	The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.; 90 - 100 = excellent; 80 - 89 = good; 70 - 79 = fair; 0 - 69 = poor	pre-operative, 1,3 and 5 years
Secondary	Mean Harris Hip Score (HHS) Pain Score to Assess Change	The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.; None or ignores it = 44 points; Slight, occasional, no compromise in activities = 40 points; Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points; Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points; Marked pain, serious limitation of activites = 10 points; Totally disabled, crippled, pain in bed, bedridden = 0 points	pre-operative, 1,3, and 5 years
Secondary	Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change	The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.; 211-300 degrees = 5 points; 161 to 210 degrees = 4 points; 101 to 160 degrees = 3 points; 61 to 100 degrees = 2 points; 31 to 60 degrees = 1 points; 0 to 30 degrees = 0 points	pre-operative, 1,3 and 5 years
Secondary	Mean SF-12 Health Survey Score to Assess Change	Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.	pre-operative, 1,3 and 5 years
Secondary	Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change	Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.	pre-operative, 1,3 and 5 years
Secondary	Implant Survivorship	Implant survivorship is determined using the Kaplan-Meier method.	10 years