Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

Not Applicable

Withdrawn

• Conditions: Osteoarthritis of Hip; Failure of Primary THA
• Interventions: Procedure: Bead placement during revision hip replacement surgery

• Registration Number: NCT01668160
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. In the past, acetabular and femoral component stability has been measured using radiostereometric analysis (RSA) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. The investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-17
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female.
2. 25 to 75 years of age.
3. Subjects requiring revision total hip replacement.
4. Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

Exclusion Criteria

1. Subjects with limited life span.

2. Subjects with difficulty in comprehending study protocol for any reason.

3. Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection.

4. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

   • A urine HCG will be done in all women of child bearing potential prior to RSA imaging at each follow-up visit. The result will be recorded in the research record.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Revision Total Hip	Bead placement during revision hip replacement surgery	patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone.

Primary Outcome Measures

Name	Time	Method
Stability of Acetabular and femoral components	1, 2, 3, 5 years after surgery	RSA films will be taken at the prescribed time intervals to measure component mothion over time.

Secondary Outcome Measures

Name	Time	Method
Wear of the polyethlene component	1, 2, 3, 5 years after surgery	The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States