Clinical trial NCT01668160: Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis
Official title: Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis of Hip
Failure of Primary THA
Keywords: clinical outcomes
radiographic outcomes
total hip arthroplasty
survivorship
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Stability of Acetabular and femoral components
timeFrame: 1, 2, 3, 5 years after surgery
Secondary outcomes:
measure: Wear of the polyethlene component
timeFrame: 1, 2, 3, 5 years after surgery
Other outcomes:
measure: Assessment/questionaire HOOS
timeFrame: Pre-op, 1, 2, 3, 5 years after surgery
measure: Assessment/Questionaires Harris Hip Score
timeFrame: Pre-op, 1, 2, 3, 5 years after surgery
measure: Assessment/Questionaire UCLA Activity Score
timeFrame: Pre-op, 1, 2, 3, 5 years after surgery
measure: Assessment/Questionaire EQ-5D
timeFrame: Pre-op, 1, 2, 3, 5 years after surgery
measure: Assessment/Questionaire Case Mix indicator
timeFrame: Pre-op, 1, 3, 5, 7, 10 years after surgery
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: