Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis. A Randomized Single-blind Trial

Norwegian University of Science and Technology1 site in 1 country48 target enrollmentMarch 2013

ConditionsOsteoarthritis, Hip

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Hip
Sponsor: Norwegian University of Science and Technology
Enrollment: 48
Locations: 1
Primary Endpoint: Difference in subsidence of femoral stems of 200 microns
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary aim of the study is to compare migration of the cemented Corail stem representing polished surfaced versions of the femoral stem. Two different methods will be used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be used in migration measurements.

Furthermore pain, postoperative outcome and patient satisfaction will be assessed.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

June 20, 2017

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Norwegian University of Science and Technology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients requiring cemented primary total hip replacement.
•Patients with a diagnosis of osteoarthritis, avascular necrosis or post-traumatic arthritis
•Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
•Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery

Exclusion Criteria

•Patients who require revision of a previously implanted total hip replacement (THR)
•Patients who will receive a THR without cement
•Patients who have had a prior procedure of osteotomy on the femur
•Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI \>35)
•Patients with active or suspected infection
•Patients with malignancy

Outcomes

Primary Outcomes

Difference in subsidence of femoral stems of 200 microns

Time Frame: change from 6th day postoperative to 24 months

Radiostereometric analysis (RSA) of implant migration: difference in translation and rotation (x-, y-, and z- axis) of the femoral stem

Secondary Outcomes

EQ-5D-5L(change from 6th day postoperative to 24 months)
Visual Assessment Scale (VAS) for pain(change from 6th day postoperative to 24 months)
Oxford Hip Score(change from 6th day postoperative to 24 months)
Harris Hip Score (HHS)(change from 6th day postoperative to 24 months)
Merle D'Aubigne scale(change from 6th day postoperative to 24 months)