OsteoarthritisBioHipLLDNCT02275494
The Influence of Leg Length Discrepancy After Total Hip Arthroplasty on Function and Quality of Life
An observational study of Osteoarthritis and Leg Length Difference, run by Sundsvall Hospital.
Trial summary
Leg length discrepancy (LLD) is a complication of THA and may result in patient dissatisfaction, gait disorder, greater trochanter pain, low back pain. In the literature, LLD is reported to vary widely among studies e.g. 6 to 35 mm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Leg Length Difference, Hip Arthroplasty
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Apr 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with unilateral primary osteoarthritis (OA) treated with THA at the orthopaedic department in Sundsvall, Sweden were considered for inclusion.
Who may be able to join
- Unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.
Who cannot join
- Secondary OA.
- Previous spinal, pelvic, or lower limb injuries or fractures.
- Bilateral coxarthrosis.
About this study
Leg length discrepancy (LLD) is a complication of THA and may result in patient dissatisfaction, gait disorder, greater trochanter pain, low back pain. In the literature, LLD is reported to vary widely among studies e.g. 6 to 35 mm. However, the threshold at which a LLD is clinically important is still a matter of debate. The aim of this study was to determine the influence of non-corrected LLD after THA on patients' reported hip function and quality of life. This prospective cohort study was conducted at Sundsvall Teaching Hospital in Sweden after it was approved by the regional ethics committee at Umeå University (No. 07-052M and No. 12-287-32M). Between September 2010 and April 2013, all patients with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion. Informed consent was obtained from all patients. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were excluded.
The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index that measures functional outcome (ref). The secondary outcome measure was the EQ-5D and visual analogue scale (VAS) scale. Patients were assessed preoperatively and at follow-up at 1 year postoperatively. The posterolateral approach was used in all operations. LLD was measured on the postoperative x-rays. patients were divided into three groups: shortening group where the operated leg was more than 5mm shorter compared with the contralateral side, the restoration control group where the operated leg was within 5mm shortening and 9mm lengthening compared with the contralateral side, and the lengthening group where the operated leg became more than 9mm longer compared with the contralateral side.
- Conditions
- Osteoarthritis, Leg Length Difference, Hip Arthroplasty
- Being tested
- Total hip arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
Cemented or uncemented total hip arthroplasty. No other intervention than observing patients operated according to routine practise at an orthopaedic department.
| Study group | Role | What they receive |
|---|---|---|
| shortening group | Shortening group where the operated leg was more than 5mm shorter compared with the contralateral side Receives: Procedure: Total hip arthroplasty | |
| Restoration group | the restoration control group where the operated leg was within 5mm shortening and 9mm lengthening compared with the contralateral side Receives: Procedure: Total hip arthroplasty | |
| Lengthening group | The lengthening group where the operated leg became more than 9mm longer compared with the contralateral side. Receives: Procedure: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Measured: 12-15 months
Secondary outcomes (2)
EQ-5D
Measured: 12-15 months
Visual analogue scale
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275494
- Sponsor's protocol ID
- Sarwar-2
- Acronym
- BioHipLLD
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2014
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ogawa K, Kabata T, Maeda T, Kajino Y, Tsuchiya H. Accurate leg length measurement in total hip arthroplasty: a comparison of computer navigation and a simple manual measurement device. Clin Orthop Surg. 2014 Jun;6(2):153-8. doi: 10.4055/cios.2014.6.2.153. Epub 2014 May 16.
PubMed 24900895Whitehouse MR, Stefanovich-Lawbuary NS, Brunton LR, Blom AW. The impact of leg length discrepancy on patient satisfaction and functional outcome following total hip arthroplasty. J Arthroplasty. 2013 Sep;28(8):1408-14. doi: 10.1016/j.arth.2012.12.009. Epub 2013 Mar 16.
PubMed 23507069McWilliams AB, Grainger AJ, O'Connor PJ, Redmond AC, Stewart TD, Stone MH. A review of symptomatic leg length inequality following total hip arthroplasty. Hip Int. 2013 Jan-Feb;23(1):6-14. doi: 10.5301/HIP.2013.10631.
PubMed 23397200Bertz A, Indrekvam K, Ahmed M, Englund E, Sayed-Noor AS. Validity and reliability of preoperative templating in total hip arthroplasty using a digital templating system. Skeletal Radiol. 2012 Sep;41(10):1245-9. doi: 10.1007/s00256-012-1431-4. Epub 2012 May 16.
PubMed 22588597Plaass C, Clauss M, Ochsner PE, Ilchmann T. Influence of leg length discrepancy on clinical results after total hip arthroplasty--a prospective clinical trial. Hip Int. 2011 Jul-Aug;21(4):441-9. doi: 10.5301/HIP.2011.8575.
PubMed 21818744O'Brien S, Kernohan G, Fitzpatrick C, Hill J, Beverland D. Perception of imposed leg length inequality in normal subjects. Hip Int. 2010 Oct-Dec;20(4):505-11. doi: 10.1177/112070001002000414.
PubMed 21157756Mahmood SS, Mukka SS, Crnalic S, Sayed-Noor AS. The Influence of Leg Length Discrepancy after Total Hip Arthroplasty on Function and Quality of Life: A Prospective Cohort Study. J Arthroplasty. 2015 Sep;30(9):1638-42. doi: 10.1016/j.arth.2015.04.012. Epub 2015 Apr 11.
PubMed 25922312
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Leg Length Discrepancy After Total Hip Arthroplasty on Function and Quality of Life
- ClinicalTrials.gov ID
- NCT02275494
- Acronym / sponsor ID
- BioHipLLD / Sarwar-2
- Conditions
- Osteoarthritis, Leg Length Difference, Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 Oct 2014 (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.
Leg length discrepancy (LLD) is a complication of THA and may result in patient dissatisfaction, gait disorder, greater trochanter pain, low back pain. In the literature, LLD is reported to vary widely among studies e.g. 6 to 35 mm. However, the threshold at which a LLD is clinically important is still a matter of debate. The aim of this study was to determine the influence of non-corrected LLD after THA on patients' reported hip function and quality of life. This prospective cohort study was conducted at Sundsvall Teaching Hospital in Sweden after it was approved by the regional ethics committee at Umeå University (No. 07-052M and No. 12-287-32M). Between September 2010 and April 2013, all patients with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion. Informed consent was obtained from all patients. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were excluded.
The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index that measures functional outcome (ref). The secondary outcome measure was the EQ-5D and visual analogue scale (VAS) scale. Patients were assessed preoperatively and at follow-up at 1 year postoperatively. The posterolateral approach was used in all operations. LLD was measured on the postoperative x-rays. patients were divided into three groups: shortening group where the operated leg was more than 5mm shorter compared with the contralateral side, the restoration control group where the operated leg was within 5mm shortening and 9mm lengthening compared with the contralateral side, and the lengthening group where the operated leg became more than 9mm longer compared with the contralateral side.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| shortening group | – | Procedure: Total hip arthroplastyShortening group where the operated leg was more than 5mm shorter compared with the contralateral side |
| Restoration group | – | Procedure: Total hip arthroplastythe restoration control group where the operated leg was within 5mm shortening and 9mm lengthening compared with the contralateral side |
| Lengthening group | – | Procedure: Total hip arthroplastyThe lengthening group where the operated leg became more than 9mm longer compared with the contralateral side. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with unilateral primary osteoarthritis (OA) treated with THA at the orthopaedic department in Sundsvall, Sweden were considered for inclusion.
Key inclusion criteria (1 listed)
- Unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.
Key exclusion criteria (3 listed)
- Secondary OA.
- Previous spinal, pelvic, or lower limb injuries or fractures.
- Bilateral coxarthrosis.
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 arthroplastyCemented or uncemented total hip arthroplasty. No other intervention than observing patients operated according to routine practise at an orthopaedic department. | Procedure or surgery | Lengthening group, Restoration group, shortening group |
Primary outcome
WOMAC
Time frame: 12-15 months
2 secondary outcomes
EQ-5D
Time frame: 12-15 months
Visual analogue scale
Time frame: 12-15 months
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 29 Oct 2015.
- Background: PubMed 24900895Ogawa K, Kabata T, Maeda T, Kajino Y, Tsuchiya H. Accurate leg length measurement in total hip arthroplasty: a comparison of computer navigation and a simple manual measurement device. Clin Orthop Surg. 2014 Jun;6(2):153-8. doi: 10.4055/cios.2014.6.2.153. Epub 2014 May 16.
- Background: PubMed 23507069Whitehouse MR, Stefanovich-Lawbuary NS, Brunton LR, Blom AW. The impact of leg length discrepancy on patient satisfaction and functional outcome following total hip arthroplasty. J Arthroplasty. 2013 Sep;28(8):1408-14. doi: 10.1016/j.arth.2012.12.009. Epub 2013 Mar 16.
- Background: PubMed 23397200McWilliams AB, Grainger AJ, O'Connor PJ, Redmond AC, Stewart TD, Stone MH. A review of symptomatic leg length inequality following total hip arthroplasty. Hip Int. 2013 Jan-Feb;23(1):6-14. doi: 10.5301/HIP.2013.10631.
- Background: PubMed 22588597Bertz A, Indrekvam K, Ahmed M, Englund E, Sayed-Noor AS. Validity and reliability of preoperative templating in total hip arthroplasty using a digital templating system. Skeletal Radiol. 2012 Sep;41(10):1245-9. doi: 10.1007/s00256-012-1431-4. Epub 2012 May 16.
- Background: PubMed 21818744Plaass C, Clauss M, Ochsner PE, Ilchmann T. Influence of leg length discrepancy on clinical results after total hip arthroplasty--a prospective clinical trial. Hip Int. 2011 Jul-Aug;21(4):441-9. doi: 10.5301/HIP.2011.8575.
- Background: PubMed 21157756O'Brien S, Kernohan G, Fitzpatrick C, Hill J, Beverland D. Perception of imposed leg length inequality in normal subjects. Hip Int. 2010 Oct-Dec;20(4):505-11. doi: 10.1177/112070001002000414.
- Results publication: PubMed 25922312Mahmood SS, Mukka SS, Crnalic S, Sayed-Noor AS. The Influence of Leg Length Discrepancy after Total Hip Arthroplasty on Function and Quality of Life: A Prospective Cohort Study. J Arthroplasty. 2015 Sep;30(9):1638-42. doi: 10.1016/j.arth.2015.04.012. Epub 2015 Apr 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Leg Length Difference, run by Sundsvall Hospital.
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 1 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 29 Oct 2015. 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.
What does the primary outcome measure?
WOMAC (time frame: 12-15 months). 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 NCT02275494, which also lists 7 linked publications.
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 29 Oct 2015.