RSA Study of Furlong Evolution With and Without Collar

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2025-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hip Replacement in Osteoarthritis Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Stem collar

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

No 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.

Group Type ACTIVE_COMPARATOR

Stem collar

Intervention Type PROCEDURE

The stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar.

Interventions

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Stem collar

The stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar.

Intervention Type PROCEDURE

Other Intervention Names

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Furlong Evolution with collar Furlong Evolution without collar

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No