Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

Mass General Brigham

Status: Withdrawn

Conditions: Osteoarthritis of Hip; Failure of Primary THA

Treatments: Procedure: Bead placement during revision hip replacement surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01668160

2012P000925

216494 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Revision Total Hip

Experimental group

Description:

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.

Treatment:

Procedure: Bead placement during revision hip replacement surgery