Tritanium® Primary Acetabular Shell Study
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|ClinicalTrials.gov Identifier: NCT01063751|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2010
Last Update Posted : December 21, 2018
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 X3® polyethylene insert alone as the bearing surface; the other half will use the MDMTM liner coupled with a compatible ADM/MDMTM 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.
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Hip||Device: Tritanium® Primary Acetabular Shell||Not Applicable|
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 CP Ti. The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® HA hemispherical acetabular 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 mm through 66 mm and is compatible with Trident® polyethylene liners 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.
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 IRB approval. Non-compliance of a study center may result in termination of the center's participation in the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2026|
Tritanium® Primary Acetabular Shell
Tritanium® Primary Acetabular Shell
Device: Tritanium® Primary Acetabular Shell
Tritanium® Primary Acetabular Shell in total hip replacement.
- Absence of acetabular revision [ Time Frame: 5 years ]To evaluate the success rate of cementless primary 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.
- Rates of Screw Fixation Usage in the Triathlon Acetabular Shell [ Time Frame: Intraoperative ]Usage of bone screw fixation will be recorded and compared between the Tritanium® Acetabular Shell group and the Trident® HA Hemispherical Shell group (Trident® X3® Polyethylene Insert Study).
- Harris Hip Score [ Time Frame: 1, 3, and 5 years ]The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
- SF-12 Heath Survey Scores [ Time Frame: 1, 3, and 5 years ]The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
- Lower Extremity Activity Scale (LEAS) Score [ Time Frame: 1, 3, and 5 years ]The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
- EQ-5D [ Time Frame: 1,2,3,4, and 5 years ]The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.
- Follow-Up Questionnaire [ Time Frame: 6, 7, 8, 9, and 10 years ]
The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. It consists of three questions:
- Patient satisfaction with the hip replacement
- Presence of any pain in the study hip
- Any surgeries performed on the study hip
- Acetabular Shell Radiographic Stability [ Time Frame: 6 weeks, 1, 3, 5 years ]Numerous parameters will be reviewed by zone, including radiolucency and migration. All data will be evaluated in order to classify each case as stable or unstable.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063751
|United States, California|
|Mercy Medical Group|
|Sacramento, California, United States, 95816|
|Coon Joint Replacement Institute|
|Saint Helena, California, United States, 94574|
|United States, Florida|
|Florida Medical Clinic|
|Tampa, Florida, United States, 33542|
|United States, Kentucky|
|Unversity of Kentucky|
|Lexington, Kentucky, United States, 40536|
|United States, Louisiana|
|Imperial Calcasieu Medical Group|
|Lake Charles, Louisiana, United States, 70601|
|United States, Maine|
|Eastern Maine Medical Center|
|Bangor, Maine, United States, 04401|
|United States, New York|
|Syracuse Orthopedic Specialists|
|Syracuse, New York, United States, 13214|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, West Virginia|
|West Virginia University|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Timothy H Izant, MD||Crouse Hospital|
|Principal Investigator:||John Noble, MD||Christus St. Patrick Hospital|
|Principal Investigator:||Ron James, MD||Mercy General Hospital|
|Principal Investigator:||John Bradford, MD||Eastern Maine Medical Center|
|Principal Investigator:||Dan Del Gaizo, MD||University of North Carolina|
|Principal Investigator:||John Diana, MD||St. Helena Hospital|
|Principal Investigator:||Stephen Duncan, MD||University of Kentucky Hospital|
|Principal Investigator:||Brock Lindsey, MD||West Virginia University Hospital|
|Principal Investigator:||Stephen Raterman, MD||Florida Hospital Wesley Chapel|