Overview

This trial is active, not recruiting.

Condition hip arthroplasty
Treatments bmd
Phase phase 4
Sponsor Ottawa Hospital Research Institute
Collaborator Stryker Nordic
Start date October 2001
End date December 2015
Trial size 50 participants
Trial identifier NCT00253838, OHREB 2001215-01H

Summary

This study compares two different hip stem components. Both hip stems used in this study allow the femur bone to attach and grow into them for stability. The main difference between the two stems is that one of the stems, the Solution® Stem, is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating, while the second stem included in the study, the Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surface and allows for a hydroxylapatite (HA) coating to be applied to the entire length of the stem. The HA coating is a thin calcium phosphate layer on the stem to encourage the bone to grow into it. We are trying to see if there is any difference in the initial bony ingrowth between the two stems and to compare the results in patients over the first two years after the surgery and then again at the five-year period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Restoration Stem
bmd non applicable
bone mineral density
(Active Comparator)
Solution stem
bmd non applicable
bone mineral density

Primary Outcomes

Measure
bone mineral density scores
time frame: pre-op, 6, 12, 24 months

Secondary Outcomes

Measure
Rates of osteolysis/radiolucent lines on radiographs WOMAC SF-12 Harris Hip Score Rate of revision Rate of complication
time frame: pre-op, 6, 12, 24, 60 months

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Candidates for revision hip arthropathy Exclusion Criteria: - Under 21 years of age

Additional Information

Official title A Randomized Controlled Trial Comparing a Titanium to a Cobalt Chrome Femoral Stem in Revision Hip Arthroplasty: A Pilot Study
Principal investigator Paul R Kim, MD, FRCSC
Description Revision total hip arthroplasty is becoming increasingly common due to the large number of primary total hip arthroplasties being performed annually. Failure of these arthroplasties has led to an increasing number of patients requiring revision arthroplasty. Various methods have been used to reconstruct the hip during a revision procedure. These have generally consisted of a cemented or uncemented femoral stem. It is now generally accepted that uncemented femoral stems have improved results over cemented stems, especially in those cases with compromised bone stock. There are two main alloys used for the femoral revision component, that is cobalt chrome and titanium. There may be certain advantages to the use of titanium, in particular, a reduction in future bone loss caused by stress shielding. Stress shielding is commonly seen with cobalt chrome implants. In order to assess this and the overall survival of these two different implants a randomized clinical trial is proposed.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.