NCT01894854

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
11.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

June 24, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

July 1, 2013

Last Update Submit

June 18, 2025

Conditions

Hip Replacement in Osteoarthritis Patients

Keywords

RadiostereometryTotal Hip ArthroplastyStem design

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Dual-energy X-ray absorptiometry (DXA)

    14 days postoperatively and after 1, 5 and 10 years

  • General health questionnaire

    Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively

  • Hip specific health questionnaire

    Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively

Study Arms (2)

Stem collar

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.

No Stem 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.

Procedure: Stem collar

Interventions

Stem collarPROCEDURE

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

Also known as: Furlong Evolution with collar, Furlong Evolution without collar
No Stem collar

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis of the hip necessitating primary hip replacement
  • A femur considered suitable for uncemented fixation of the stem

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedics, Skane University Hospital, Lund University

Lund, Skåne County, 221 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 34841462DERIVED

Study Officials

  • Gunnar Flivik, MD PhD

    Dept of Orthopedics, Skane University Hospital, Lund University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD PhD

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 10, 2013

Study Start

October 1, 2012

Primary Completion

July 1, 2013

Study Completion

March 1, 2025

Last Updated

June 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)