Hip Replacement in Osteoarthritis PatientsNCT01894854
RSA Study of Furlong Evolution With and Without Collar
A study testing Stem collar in people with Hip Replacement in Osteoarthritis Patients, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hip Replacement in Osteoarthritis Patients
- What is being tested?
- Stem collar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopedics, Skane University Hospital, Lund University
Lund, Skåne County, 221 85
About this study
Official 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.
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
- Being tested
- Stem collar
- Keywords
- Radiostereometry, Total Hip Arthroplasty, Stem design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem collarProcedure or surgery
Also called Furlong Evolution with collar, Furlong Evolution without collar
The stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Stem collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionMar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip Replacement in Osteoarthritis PatientsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- JRI Orthopaedics Ltd
- Responsible party
- Principal investigator, Gunnar Flivik, Region Skane
- Investigators
- Gunnar Flivik, MD PhD, Principal investigator, Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894854
- Sponsor's protocol ID
- Furlong Evolution_EW
- Status last verified
- Apr 2025
- First submitted
- 1 Jul 2013
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 34841462
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01894854
- Acronym / sponsor ID
- Furlong Evolution_EW
- Keywords
- Radiostereometry, Total Hip Arthroplasty, Stem design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- JRI Orthopaedics Ltd
- Study start
- Oct 2012 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Mar 2025 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Stem collarThe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Rheumatoid arthritis
- Malignant disease
- Severe osteoporosis
- Earlier fracture or operation in the hip to be operated on
- Peroperative fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem collarAlso: Furlong Evolution with collar, Furlong Evolution without collarThe stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar. | Procedure or surgery | No Stem collar |
Primary outcome
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.
3 secondary outcomes
Dual-energy X-ray absorptiometry (DXA)
Time frame: 14 days postoperatively and after 1, 5 and 10 years
General health questionnaire
Time frame: Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively
Hip specific health questionnaire
Time frame: Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Derived from this study: PubMed 34841462Belfrage 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Flivik, MD PhD principal investigator
Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stem collar in people with Hip Replacement in Osteoarthritis Patients, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiostereometric Analysis (RSA) (time frame: The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.