Radiostereometric Analysis (RSA) and DEXA to Evaluate Fixation and Wear of the Restoration ADM Acetabular System
Prospective Clinical Study Using Radiostereometric Analysis (RSA) and DEXA to Evaluate Fixation and Wear of the Restoration ADM Acetabular System
1 other identifier
observational
30
1 country
1
Brief Summary
The dual mobility design concept for acetabular liners, as is used in the Restoration ADM Acetabular System, has been applied in various implants since its introduction by Gilles Bousquet in France in 1976. Dual mobility cups have shown good clinical results and have been particularly lauded for low incidence of dislocations. However, the wear performance of this design concept has not been proven to date. As wear particles are a possible contributing factor in aseptic loosening, the assessment of wear and fixation is an important step in proving this implant design. The proposed study will combine RSA and peri-prosthetic bone mineral density as well as outcome questionnaires to provide a complete in vivo evaluation of prosthesis fixation, polyethylene wear, and objective and subjective outcomes for the Restoration ADM Acetabular System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 19, 2021
August 1, 2021
4.7 years
January 7, 2011
August 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RSA migration
3 years
Secondary Outcomes (2)
RSA wear
3 years
Questionnaires
3 years
Study Arms (1)
ADM
ADM Cup
Interventions
Eligibility Criteria
Osteoarthritis of the hip
You may qualify if:
- Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
You may not qualify if:
- Inflammatory arthritis
- BMI \>40
- Post-traumatic arthritis of the hip
- Prior arthroplasty with the affected hip
- Hip dysplasia
- Active or prior infection
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital District Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Dunbar, MD, FRCSC, PhD
Dalhousie University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 10, 2011
Study Start
November 1, 2011
Primary Completion
July 1, 2016
Study Completion
December 1, 2019
Last Updated
August 19, 2021
Record last verified: 2021-08