Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis of Hip; Failure of Primary THA
• Intervention / Treatment: Procedure: Bead placement during revision hip replacement surgery

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment/questionaire HOOS	Hip disability and Osteoarthritis Outcome Score	Pre-op, 1, 2, 3, 5 years after surgery
Assessment/Questionaires Harris Hip Score	Hip specific questionaire	Pre-op, 1, 2, 3, 5 years after surgery
Assessment/Questionaire UCLA Activity Score	Measure of activity level	Pre-op, 1, 2, 3, 5 years after surgery
Assessment/Questionaire EQ-5D	General health and cost effectiveness measure	Pre-op, 1, 2, 3, 5 years after surgery
Assessment/Questionaire Case Mix indicator	Determines comorbidities	Pre-op, 1, 3, 5, 7, 10 years after surgery

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: total hip arthroplasty; survivorship; clinical outcomes; radiographic outcomes
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 2012P000925; 216494 (Other Grant/Funding Number: MGH Orhtopaedic Department Funds 216494)