MedTrace Logo

Radiostereometric Analysis (RSA) and DEXA to Evaluate Fixation and Wear of the Restoration ADM Acetabular System

NCT01273324 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2021-08-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

ADM Cup

ADM Cup

Sponsors & Collaborators

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Michael Dunbar, MD, FRCSC, PhD · Dalhousie University

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-07-31
Completion
2019-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01273324 on ClinicalTrials.gov