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NCT Number: NCT01894854

RSA Study of Furlong Evolution With and Without Collar

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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Key information

Conditions

Hip Replacement in Osteoarthritis Patients

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedics, Skane University Hospital, Lund University

Lund, Skåne County, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stem collar

Procedure

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

Other names: Furlong Evolution with collar, Furlong Evolution without collar

Primary outcomes

  1. Radiostereometric Analysis (RSA)

    Time frame: 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 outcomes

  1. Dual-energy X-ray absorptiometry (DXA)

    Time frame: 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.

  2. General health questionnaire

    Time frame: 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

  3. Hip specific health questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • JRI Orthopaedics Ltd

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2025
First posted
Jul 10, 2013
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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