Tritanium® Primary Acetabular Shell Study
Summary
This study will be a prospective, non-randomized evaluation of the Tritanium® Primary Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. The first 120 cases enrolled will receive the Tritanium® Primary Acetabular Shell. An additional 120 cases will receive the Tritanium® Primary Acetabular Shell with periapatite (PA), a biological coating.
The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Primary Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 10 years postoperative.
Study Design
Allocation: Non-Randomized, Control: Historical Control, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hip Arthroplasty
Intervention
Tritanium® Primary Acetabular Shell, Tritanium® Primary Acetabular Shell with Periapatite
Status
Not yet recruiting
Source
Stryker Orthopaedics
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01063751
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Breast Implants
Implants used to reconstruct and/or cosmetically enhance the female breast. They have an outer shell or envelope of silicone elastomer and are filled with either saline or silicone gel. The outer shell may be either smooth or textured.
Nuts
Botanically, a type of single-seeded fruit in which the pericarp enclosing the seed is a hard woody shell. In common usage the term is used loosely for any hard, oil-rich kernel. Of those commonly eaten, only hazel, filbert, and chestnut are strictly nuts. Walnuts, pecans, almonds, and coconuts are really drupes. Brazil nuts, pistachios, macadamias, and cashews are really seeds with a hard shell derived from the testa rather than the pericarp.
Osteoarthritis, Hip
Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion.
Hip Dislocation, Congenital
Congenital dislocation of the hip generally includes subluxation of the femoral head, acetabular dysplasia, and complete dislocation of the femoral head from the true acetabulum. This condition occurs in approximately 1 in 1000 live births and is more common in females than in males.
Clinical Trials
Trident® Tritanium™ Acetabular Shell Revision Study
The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 2...
Cementless Alumina-Alumina Total Hip and Hybrid
Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip stem.
The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell,...
Acetabular Fractures of Both Columns
The purpose of this research is to study a specific acetabular (hip socket) fracture pattern and how its treatment affects the functional, clinical, and x-ray outcomes. There are no exper...
PubMed Articles
For the past 17 years, we have favored treating patients with polyethylene wear and osteolysis by performing a liner exchange with retention of the old shell when possible. Using our institutional dat...
BACKGROUND: Several studies have reported that the transverse acetabular ligament (TAL) can be used to orient the acetabular component during total hip arthroplasty and that it can be identified in ne...
We identified 128 revision total hip arthroplasties from 1993 to 2005 involving a well-fixed Harris-Galante Porous (HGP)-I or HGP-II acetabular component with minimum 2-year post-revision follow-up. T...
Acetabular Component Positioning Using Anatomic Landmarks of the Acetabulum.
BACKGROUND: The acetabular cup should be properly oriented to prevent dislocation and to reduce wear. However, achieving proper cup placement is challenging with potentially large variations of cup po...
Shell deformation of resurfacing and all-metal modular cups following press-fit implantation has been reported, but not for conventional metal-backed cups with polyethylene liners. The deformation of...
