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Evaluation of Cemented and Cementless Fixation of Dual-mobility Hip Prosthesis in Elderly Patients With Osteoarthritis

NCT02404727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-10-24

No results posted yet for this study

Summary

The aim of this project is to investigate prosthesis fixation in the bone, respectively cemented and uncemented operation method of Avantage® dual-mobility acetabular cup in elderly patients, wear of the plastic in dual-mobility hip prosthesis and evaluate the clinical function, patient satisfaction and possible complications.

Patients included in this study suffer from osteoarthritis of the hip.

Conditions

  • Osteoarthritis, Hip
  • Arthropathy of Hip

Interventions

PROCEDURE

cup fixation

All patients will preoperatively, 3 months, 1 year, 2 year and 5 year have the hip DXA scanned, answer PROM, X-ray for RSA analysis and wear measurements, and wear accelerometry chip 14 days prior each outward clinic visit for movement analysis.

DEVICE

Avantage® Cup

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Torben B. Hansen, Ph.D., Professor · Department of Orthopaedic Surgery, Hospital Unit West, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-01-31
Completion
2018-03-31

Countries

  • Denmark

Study Locations

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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 NCT02404727 on ClinicalTrials.gov