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NCT01063751 · ClinicalTrials.gov registry record · NA
Tritanium® Primary Acetabular Shell Study
A NA study, sponsored by Stryker Orthopaedics.
- Terminated
- Registry status
- NA
- Development phase
- 275
- Enrollment target
NCT01063751: Clinical Trial NA study, sponsored by Stryker Orthopaedics.
NCT01063751 is a NA study that was terminated before completion, run by Stryker Orthopaedics. The registered enrollment target is 275 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01063751, a NA study, was terminated before completion, sponsored by Stryker Orthopaedics.
- TERMINATED
- Registry status
- NA
- Development phase
- 275 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Tritanium® Primary Acetabular Shell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2011-07 |
| Est. Completion | 2023-12-30 |
| Phase | NA |
Why NCT01063751 stopped before completion
NCT01063751 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Tritanium® Primary Acetabular Shell is the first listed.
NCT01063751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01063751 about?
NCT01063751 is a clinical study titled "Tritanium® Primary Acetabular Shell Study". 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 ...
What is the current status of trial NCT01063751?
This trial is currently terminated. It is a NA study. The enrollment target is 275 participants. The study started on 2011-07. Estimated completion is 2023-12-30.
What interventions are being tested in trial NCT01063751?
The interventions under investigation include: Tritanium® Primary Acetabular Shell (DEVICE).
Who is sponsoring clinical trial NCT01063751?
This trial is sponsored by Stryker Orthopaedics, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01063751's enrollment target sits among peer trials
275 383rd of 2000 higher than 1,616 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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