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Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

NCT ID: NCT01668160

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Osteoarthritis of Hip Failure of Primary THA

Keywords

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clinical outcomes radiographic outcomes total hip arthroplasty survivorship

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Revision Total Hip

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.

Group Type EXPERIMENTAL

Bead placement during revision hip replacement surgery

Intervention Type PROCEDURE

Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components

Interventions

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Bead placement during revision hip replacement surgery

Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Charles R. Bragdon

Reseach scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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216494

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012P000925

Identifier Type: -

Identifier Source: org_study_id