NCT01668160

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

7.9 years

First QC Date

August 10, 2012

Last Update Submit

November 4, 2013

Conditions

Osteoarthritis of HipFailure of Primary THA

Keywords

clinical outcomesradiographic outcomestotal hip arthroplastysurvivorship

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Wear of the polyethlene component

    1, 2, 3, 5 years after surgery

Other Outcomes (5)

  • Assessment/questionaire HOOS

    Pre-op, 1, 2, 3, 5 years after surgery

  • Assessment/Questionaires Harris Hip Score

    Pre-op, 1, 2, 3, 5 years after surgery

  • Assessment/Questionaire UCLA Activity Score

    Pre-op, 1, 2, 3, 5 years after surgery

  • +2 more other outcomes

Study Arms (1)

Revision Total Hip

EXPERIMENTAL

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

Interventions

Bead placement during revision hip replacement surgeryPROCEDURE

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

Revision Total Hip

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female.
  • to 75 years of age.
  • Subjects requiring revision total hip replacement.
  • Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

You may not qualify if:

  • Subjects with limited life span.
  • Subjects with difficulty in comprehending study protocol for any reason.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reseach scientist

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 17, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

US(1)