Overview

This trial is active, not recruiting.

Condition hip replacement in osteoarthritis patients
Treatment stem collar
Sponsor Region Skane
Collaborator JRI Orthopaedics Ltd, United Kingdom
Start date October 2012
End date July 2013
Trial size 50 participants
Trial identifier NCT01894854, Furlong Evolution_EW

Summary

The aim of this study is to further investigate the clinical and radiological importance of design changes in cementless hip prosthesis. The investigators have earlier evaluated the classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore, comes with and without a collar, and the investigators are going to randomize between the two. The investigators hypothesize that the new design will be easier to implant and will present equal or less migration than the older designs which would imply a favourable outcome in the long term. The investigators further hypothesize that the collar play no major part for the long term migration and bone remodelling.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(No Intervention)
The stem has two versions, one with and one without a collar. This arm will have stems with a collar. The classical Furlong HAC had a collar.
(Active Comparator)
The stem has two versions, one with and one without a collar. This arm will have stems without a collar. The classical Furlong HAC had a collar.
stem collar Furlong Evolution with collar
The stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar.

Primary Outcomes

Measure
Radiostereometric Analysis (RSA)
time frame: The first postoperative day, 14 days, 3 months, 1 and 2 years

Secondary Outcomes

Measure
Dual-energy X-ray absorptiometry (DXA)
time frame: 14 days postoperatively and after 1 year
General health questionnaire
time frame: Preoperatively (3-4 weeks) and 1 and 2 years postoperatively
Hip specific health questionnaire
time frame: Preoperatively (3-4 weeks) and 1 and 2 years postoperatively

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Primary osteoarthritis of the hip necessitating primary hip replacement - A femur considered suitable for uncemented fixation of the stem - Biological age <75 years old at the inclusion time of the study. Exclusion Criteria: - Rheumatoid arthritis - Malignant disease - Severe osteoporosis - Earlier fracture or operation in the hip to be operated on - Peroperative fracture - Ongoing corticosteroid (oral) or immunosuppressive medication - Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.

Additional Information

Official title Evaluation of the Furlong Evolution Uncemented Hip Prosthesis With Special Emphasize on the Use of Collared Design or Not. A Prospective, Randomized Study Evaluated by RadioStereometric Analysis (RSA) and DXA.
Principal investigator Gunnar Flivik, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Region Skane.