Tritanium® Primary Acetabular Shell Study
Reason given: As longitudinal patient follow-up continues to lag, Stryker has determined that the study is no longer able to meet the regulatory requirements this study intends to support. Termination is not related to any safety concerns with the products.
Key facts
- Where
- Bangor, Lake Charles, Lexington, Morgantown, St. Helena, Syracuse, and Tampa, United StatesSee the 7 sites
Where in United States
- Northern Light Eastern Maine Medical CenterBangor, United StatesNo longer taking part
- Center for Orthopaedics and Spine, LLPLake Charles, United StatesNo longer taking part
- University of Kentucky Research FoundationLexington, United StatesNo longer taking part
- West Virginia UniversityMorgantown, United StatesNo longer taking part
- Adventist Health St. HelenaSt. Helena, United StatesNo longer taking part
- Syracuse Orthopedic Specialists, P.C.Syracuse, United StatesNo longer taking part
- Florida Medical ClinicTampa, United StatesNo longer taking part
Trial details
- Who runs it
- Stryker Orthopaedics
- Trial code
- NCT01063751
- Record updated
- 16 April 2025
- Original description
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.Read full original descriptionShow less
A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell
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.
Inclusion: 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.
Exclusion: 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; G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation; 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; F. Patient has a Body Mass Index (BMI) ≥ 40; H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device; L. Patient has a known sensitivity to device materials; M. Patient is a prisoner.