Tritanium® Primary Acetabular Shell Study

NCT01063751 | Terminated Results

• 1 other identifier: 69
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 7

Brief Summary

This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the Trident® X3® polyethylene insert alone as the bearing surface; the other half will use the modular dual mobility (MDM™) liner coupled with a compatible anatomic dual mobility (ADM™)/MDM™ X3® insert as the bearing surface. The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Osteoarthritis; Traumatic arthritis; Avascular Necrosis

Outcome Measures

Primary Outcomes (1)

• Absence of Acetabular Revision

  To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices.

  5 years

Secondary Outcomes (7)

• Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell

  Intraoperative

• Harris Hip Score

  1, 3, and 5 years

• Short Form- 12 (SF-12) Heath Survey Scores

  1, 3, and 5 years

• Lower Extremity Activity Scale (LEAS) Score

  1, 3, and 5 years

• EuroQol Five-Dimensional (EQ-5D)

  1,2,3,4, and 5 years

Study Arms (1)

Tritanium® Primary Acetabular Shell

OTHER

Tritanium® Primary Acetabular Shell

Device: Tritanium® Primary Acetabular Shell

Interventions

Tritanium® Primary Acetabular Shell DEVICE

Tritanium® Primary Acetabular Shell in total hip replacement.

Tritanium® Primary Acetabular Shell

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
• B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
• C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
• D. Patient is a candidate for a primary cementless total hip replacement.
• E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

• F. Patient has a Body Mass Index (BMI) ≥ 40.
• G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
• H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
• I. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
• J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
• K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
• L. Patient has a known sensitivity to device materials.
• M. Patient is a prisoner.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (7)

Adventist Health St. Helena

St. Helena, California, 94574, United States

Location

Florida Medical Clinic

Tampa, Florida, 33542, United States

Location

University of Kentucky Research Foundation

Lexington, Kentucky, 40536, United States

Location

Center for Orthopaedics and Spine, LLP

Lake Charles, Louisiana, 70601, United States

Location

Northern Light Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Syracuse Orthopedic Specialists, P.C.

Syracuse, New York, 13214, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Filesha Haniff / Clinical Study Manager
• Organization: Stryker - Joint Replacement

filesha.haniff@stryker.com

1 470.528.9214

Study Officials

• Kevin Kopko, MD

  Syracuse Orthopedic Specialists, P.C.

  PRINCIPAL INVESTIGATOR

• John Noble, MD

  Center for Orthopaedics and Spine, LLP

  PRINCIPAL INVESTIGATOR

• Carmen Crofoot, MD

  Northern Light Eastern Maine Medical Center

  PRINCIPAL INVESTIGATOR

• John Diana, MD

  Adventist Health St. Helena

  PRINCIPAL INVESTIGATOR

• Stephen Duncan, MD

  University of Kentucky Research Foundation

  PRINCIPAL INVESTIGATOR

• Brock Lindsey, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Stephen Raterman, MD

  Florida Medical Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: July 1, 2011
• Primary Completion: May 5, 2022
• Study Completion: December 30, 2023
• Last Updated: April 16, 2025
• Results First Posted: January 16, 2024

Record last verified: 2024-12

Locations

US (7)