Osteoarthritis, HipNCT00764335
Unilateral vs Bilateral Total Hip Arthroplasty
An observational study of Osteoarthritis, Hip, run by Norwegian University of Science and Technology.
Trial summary
The purpose of the present study was to determine whether unilaterally operated total hip arthroplasty (THA) patients were superior to bilaterally operated THA patients with respect to aerobic endurance capacity, muscle strength and gait patterns 3-5 years after surgery, and to what extent medial femoral head offset… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- total hip arthroplasty one side and total hip arthroplasty both sides
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jul 2009
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects selected from orthopaedic out-patient department
Who may be able to join
- Undergone hip surgery 3-5 years ago
- Age < 70 years
Who cannot join
- Heart or lung diseases
- Malign diseases
- No muscle/skeletal diseases that compromises testing
About this study
Official title: Unilateral vs Bilateral Total Hip Arthroplasty - the Influence of Medial Femoral Head Offset and Effects on Strength and Aerobic Endurance Capacity
The purpose of the present study was to determine whether unilaterally operated total hip arthroplasty (THA) patients were superior to bilaterally operated THA patients with respect to aerobic endurance capacity, muscle strength and gait patterns 3-5 years after surgery, and to what extent medial femoral head offset (FO) influenced hip abductor strength.
- Conditions
- Osteoarthritis, Hip
- Being tested
- total hip arthroplasty one side, total hip arthroplasty both sides
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplasty one sideProcedure or surgery
unilateral total hip arthroplasty
total hip arthroplasty both sidesProcedure or surgery
bilateral total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| unilateral normal | total hip arthroplasty one side, normal offset of medial femoral head Receives: Procedure: total hip arthroplasty one side | |
| bilateral normal | total hip arthroplasty both sides, normal offset of medial femoral head Receives: Procedure: total hip arthroplasty both sides | |
| bilateral abnormal offset | total hip arthroplasty both sides, abnormal offset of medial femoral head Receives: Procedure: total hip arthroplasty both sides | |
| controls | Healthy, age-matched control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionJul 2009
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 Osteoarthritis, HipStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- OrtoMedic A/S, Oslo, Scandinavian Customized Prosthesis (SCP)
- Responsible party
- Sponsor
- Investigators
- Jan Hoff, PhD prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764335
- Sponsor's protocol ID
- 4.2005.1527b
- Status last verified
- Mar 2018
- First submitted
- 1 Oct 2008
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Husby VS, Bjorgen S, Hoff J, Helgerud J, Benum P, Husby OS. Unilateral vs. bilateral total hip arthroplasty - the influence of medial femoral head offset and effects on strength and aerobic endurance capacity. Hip Int. 2010 Apr-Jun;20(2):204-14. doi: 10.1177/112070001002000211.
PubMed 20544648
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral vs Bilateral Total Hip Arthroplasty - the Influence of Medial Femoral Head Offset and Effects on Strength and Aerobic Endurance Capacity
- ClinicalTrials.gov ID
- NCT00764335
- Acronym / sponsor ID
- 4.2005.1527b
- Conditions
- Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- OrtoMedic A/S, Oslo, Scandinavian Customized Prosthesis (SCP)
- Study start
- Jan 2007 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Oct 2008 (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 purpose of the present study was to determine whether unilaterally operated total hip arthroplasty (THA) patients were superior to bilaterally operated THA patients with respect to aerobic endurance capacity, muscle strength and gait patterns 3-5 years after surgery, and to what extent medial femoral head offset (FO) influenced hip abductor strength.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| unilateral normal | – | Procedure: total hip arthroplasty one sidetotal hip arthroplasty one side, normal offset of medial femoral head |
| bilateral normal | – | Procedure: total hip arthroplasty both sidestotal hip arthroplasty both sides, normal offset of medial femoral head |
| bilateral abnormal offset | – | Procedure: total hip arthroplasty both sidestotal hip arthroplasty both sides, abnormal offset of medial femoral head |
| controls | – | –Healthy, age-matched control group |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects selected from orthopaedic out-patient department
Key inclusion criteria (2 listed)
- Undergone hip surgery 3-5 years ago
- Age < 70 years
Key exclusion criteria (3 listed)
- Heart or lung diseases
- Malign diseases
- No muscle/skeletal diseases that compromises testing
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 |
|---|---|---|
| total hip arthroplasty one sideunilateral total hip arthroplasty | Procedure or surgery | unilateral normal |
| total hip arthroplasty both sidesbilateral total hip arthroplasty | Procedure or surgery | bilateral abnormal offset, bilateral normal |
Primary outcome
Not reported in the source record.
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 20 Mar 2018.
- Results publication: PubMed 20544648Husby VS, Bjorgen S, Hoff J, Helgerud J, Benum P, Husby OS. Unilateral vs. bilateral total hip arthroplasty - the influence of medial femoral head offset and effects on strength and aerobic endurance capacity. Hip Int. 2010 Apr-Jun;20(2):204-14. doi: 10.1177/112070001002000211.
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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.
Jan Hoff, PhD prof study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip, run by Norwegian University of Science and Technology.
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 2 inclusion and 3 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764335, 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 20 Mar 2018.