Clinical trial NCT00958191: Trident® X3 Polyethylene Insert Study
Official title: An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Linear Wear Rate at 5 Years
timeFrame: 5 years
measure: Rate of Incidence of Revision of Component for Any Reason
timeFrame: 5 year
Secondary outcomes:
measure: Linear Wear Rate of the Trident X3 Polyethylene Insert
timeFrame: 2, 3 and 4 year films collected; 3 and 4 year wear assessed
measure: Volumetric Wear Rate of the Trident X3 Polyethylene Insert
timeFrame: 2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed
measure: Radiographic Stability
timeFrame: 1,2,3,4 and 5 years
measure: Mean Harris Hip Score (HHS) to Assess Change
timeFrame: pre-operative, 1,3 and 5 years
measure: Mean Harris Hip Score (HHS) Pain Score to Assess Change
timeFrame: pre-operative, 1,3, and 5 years
measure: Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change
timeFrame: pre-operative, 1,3 and 5 years
measure: Mean SF-12 Health Survey Score to Assess Change
timeFrame: pre-operative, 1,3 and 5 years
measure: Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change
timeFrame: pre-operative, 1,3 and 5 years
measure: Implant Survivorship
timeFrame: 10 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Effingham
country: United States
facility: Bonutti Research Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Lansing
country: United States
facility: J. Wesley Mesko, MD
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kearney
country: United States
facility: Good Samaritan Hospital
state: Nebraska
city: Pittsburgh
country: United States
facility: Greater Pittsburgh Orthopaedics Assoc
state: Pennsylvania
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
affiliation: Greater Pittsburgh Orthopaedic Association
name: James D'Antonio, MD
role: STUDY_CHAIR
affiliation: New England Baptist Hospital Deptartment of Orthopaedics
name: Benjamin Bierbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bonutti Clinic
name: Peter Bonutti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: William Capello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic Department of Orthopaedic Surgery
name: Michael Taunton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont College of Medicine Department of Orthopaedics & Rehabilitation
name: Robert Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Orthopaedic Center
name: J. Wesley Mesko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory Orthopaedics
name: James R Roberson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New West Orthopaedics
name: John Wright, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New England Baptist Hospital Department of Orthopaedics
name: Daniel Ward, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Russell Meldrum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: J. Andrew Parr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Steven Incavo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory Orthopaedics
name: Greg Erens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic Department of Orthopaedic Surgery
name: Robert Trousdale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic Department of Orthopaedic Surgery
name: Alren Hanssen, MD
role: PRINCIPAL_INVESTIGATOR
References: