RSA Study of Furlong Evolution With and Without Collar

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Replacement in Osteoarthritis Patients
• Intervention / Treatment: Procedure: Stem collar

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 221 85
      • Department of Orthopedics, Skåne University Hospital, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.	Procedure: Stem collar; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiostereometric Analysis (RSA)	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.	The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dual-energy X-ray absorptiometry (DXA)	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.	14 days postoperatively and after 1, 5 and 10 years
General health questionnaire	EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome over time	Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively
Hip specific health questionnaire	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.	Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: JRI Orthopaedics Ltd
• Investigators: Principal Investigator: Gunnar Flivik, MD PhD, Dept of Orthopedics, Skane University Hospital, Lund University, Sweden

Publications and helpful links

General Publications

• Belfrage O, Weber E, Sundberg M, Flivik G. Preserved periprosthetic bone stock at 5 years post-operatively with uncemented short hip stem in both collared and collarless version. Arch Orthop Trauma Surg. 2022 Nov;142(11):3489-3496. doi: 10.1007/s00402-021-04225-z. Epub 2021 Nov 29.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimated): July 10, 2013

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Radiostereometry; Stem design
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Furlong Evolution_EW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO