N/A
N=190
Trident® Tritanium™ Acetabular Shell Revision Study
Arthroplasty, Replacement, Hip
Bottom Line
View on ClinicalTrials.gov: NCT00535626 ↗Enrolled (actual)
190
Serious AEs
18.0%
Results posted
Nov 2017
Primary outcome: Primary: Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation — 4 hips
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trident® Tritanium™ Acetabular Shell (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Stryker Orthopaedics
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation |
4 | — |
| SECONDARY Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits |
53.40; 79.46; 86.11; 85.34; 86.56; 83.87 | <0.0001 sig |
| SECONDARY Change in SF-36 From Pre-operative to Post-operative Visits |
33.26; 38.9; 43.04; 43.55; 43.54; 42.76 | <0.0001 sig |
| SECONDARY Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones |
3; 0; 0; 0; 0; 0 | — |
| SECONDARY Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative |
8.32; 9.25; 10.5; 10.37; 10.6; 10.25 | 0.0011 sig |
Summary
The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.
Eligibility Criteria
Inclusion Criteria
- Males and non-pregnant females, 21-85 years of age at the time of surgery.
- Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
- Patient has signed an IRB approved study consent form.
- Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.
Exclusion Criteria
- Patient is morbidly obese, BMI > 40.
- Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.
- Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days).
- Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- Patient has an active or suspected latent infection on or about the hip joint.
- Patient is a prisoner.
Data sourced from ClinicalTrials.gov (NCT00535626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.