Clinical trial NCT01063751: Tritanium® Primary Acetabular Shell Study
Official title: A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Osteoarthritis
Traumatic arthritis
Avascular Necrosis
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from Commercially Pure Titanium (CPTi). The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® hemispherical acetabular (HA) shells. The device is designed with a roughened surface and high coefficient of friction to resist micromotion and promote initial fixation. The Tritanium® Acetabular Shell, intended for use in a cementless application, is available in sizes from 44 millimeter (mm) through 66 mm and is compatible with Trident® polyethylene insert and acetabular screws. This advanced technology is designed to address the need for improved initial and biological fixation. Data in support of these marketing claims will be collected in the Tritanium® Primary Acetabular Shell Study.

A prospective, post-market, multi-center design will be employed. Radiographs will be assessed by an independent reviewer.

Cases will be enrolled at 7 to 12 centers. The enrollment goal ranges from 20 to 34 cases implanted with the Tritanium® Acetabular Shell per center. The enrollment goal range is dependent upon the number of participating centers as well as the relative rates of enrollment of the two treatment groups. Although a range is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the overall enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) approval. Non-compliance of a study center may result in termination of the center's participation in the study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Absence of Acetabular Revision
timeFrame: 5 years
Secondary outcomes:
measure: Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell
timeFrame: Intraoperative
measure: Harris Hip Score
timeFrame: 1, 3, and 5 years
measure: Short Form- 12 (SF-12) Heath Survey Scores
timeFrame: 1, 3, and 5 years
measure: Lower Extremity Activity Scale (LEAS) Score
timeFrame: 1, 3, and 5 years
measure: EuroQol Five-Dimensional (EQ-5D)
timeFrame: 1,2,3,4, and 5 years
measure: Follow-Up Questionnaire
timeFrame: 6, 7, 8, 9, and 10 years
measure: Acetabular Shell Radiographic Stability
timeFrame: 6 weeks, 1, 3, 5 years
Other outcomes:
Locations:
city: Saint Helena
country: United States
facility: Adventist Health St. Helena
state: California
city: Tampa
country: United States
facility: Florida Medical Clinic
state: Florida
city: Lexington
country: United States
facility: University of Kentucky Research Foundation
state: Kentucky
city: Lake Charles
country: United States
facility: Center for Orthopaedics and Spine, LLP
state: Louisiana
city: Bangor
country: United States
facility: Northern Light Eastern Maine Medical Center
state: Maine
city: Syracuse
country: United States
facility: Syracuse Orthopedic Specialists, P.C.
state: New York
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Syracuse Orthopedic Specialists, P.C.
name: Kevin Kopko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Orthopaedics and Spine, LLP
name: John Noble, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Light Eastern Maine Medical Center
name: Carmen Crofoot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adventist Health St. Helena
name: John Diana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky Research Foundation
name: Stephen Duncan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Brock Lindsey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Medical Clinic
name: Stephen Raterman, MD
role: PRINCIPAL_INVESTIGATOR
References: