Failure of Primary THA, Osteoarthritis of Hip
Conditions
Keywords
clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship
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.
Interventions
PROCEDUREBead 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
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment/Questionaire UCLA Activity Score | Pre-op, 1, 2, 3, 5 years after surgery | Measure of activity level |
| Assessment/questionaire HOOS | Pre-op, 1, 2, 3, 5 years after surgery | Hip disability and Osteoarthritis Outcome Score |
| Assessment/Questionaire Case Mix indicator | Pre-op, 1, 3, 5, 7, 10 years after surgery | Determines comorbidities |
| Assessment/Questionaire EQ-5D | Pre-op, 1, 2, 3, 5 years after surgery | General health and cost effectiveness measure |
| Assessment/Questionaires Harris Hip Score | Pre-op, 1, 2, 3, 5 years after surgery | Hip specific questionaire |
Countries
United States
Outcome results
None listed