RSA Study of Furlong Evolution With and Without Collar

Not Applicable

Active, not recruiting

• Conditions: Hip Replacement in Osteoarthritis Patients
• Interventions: Procedure: Stem collar

• Registration Number: NCT01894854
• Lead Sponsor: Region Skane

Brief 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.

We will now do a 10 year follow up of the patients including RSA, DXA and PROMS

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-07
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Stem collar	Stem collar	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.

Primary Outcome Measures

Name	Time	Method
Radiostereometric Analysis (RSA)	The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years	This will measure the change in migration (translation and rotation around the x-, y-, and z-axis of the hip) over time. The migration pattern the first 2 years can predict the long term outcome.

Secondary Outcome Measures

Name	Time	Method
Dual-energy X-ray absorptiometry (DXA)	14 days postoperatively and after 1, 5 and 10 years	This will measure the change in bone density around the prosthesis during the first important year. This will tell if there is a bone resorption around the stem or cup.
General health questionnaire	Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively	EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome over time
Hip specific health questionnaire	Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively	Hip disability and Osteoarthritis Outcome Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients function and pain situation.

Trial Locations

Locations (1)

Department of Orthopedics, Skane University Hospital, Lund University; 🇸🇪 Lund, Skåne, Sweden