Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, hip
Treatment trident® tritanium™ acetabular shell
Sponsor Stryker Orthopaedics
Start date November 2006
End date December 2016
Trial size 245 participants
Trial identifier NCT00535626, 61

Summary

The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
trident® tritanium™ acetabular shell
Trident® Tritanium™ Acetabular Shell

Primary Outcomes

Measure
Rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation
time frame: 5 years postoperative

Secondary Outcomes

Measure
Change in Harris Hip Score (HHS) from pre-operative to post-operative visits
time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Change in SF-36 from pre-operative to post-operative visits
time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Radiographic Outcomes: Radiolucency greater than 2mm in all zones
time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Radiographic Outcomes: Migration greater than 5mm in any direction
time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Change in Lower Extremity Activity Scale from pre-operative to post-operative
time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

Inclusion Criteria: 1. Males and non-pregnant females, 21-85 years of age at the time of surgery. 2. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component. 3. Patient has signed an IRB approved study consent form. 4. Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations. Exclusion Criteria: 1. Patient is morbidly obese, BMI > 40. 2. Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration. 3. Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days). 4. Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 5. Patient has an active or suspected latent infection on or about the hip joint. 6. Patient is a prisoner.

Additional Information

Official title A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell
Principal investigator Michael Masini, MD
Description Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection. Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation. Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system. It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events. The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Stryker Orthopaedics.