NCT02275494

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

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

September 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

October 23, 2014

Last Update Submit

October 28, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • WOMAC

    12-15 months

Secondary Outcomes (2)

  • EQ-5D

    12-15 months

  • Visual analogue scale

    12-15 months

Study Arms (3)

shortening group

Shortening group where the operated leg was more than 5mm shorter compared with the contralateral side

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

Procedure: Total hip arthroplasty

Lengthening group

The lengthening group where the operated leg became more than 9mm longer compared with the contralateral side.

Procedure: Total hip arthroplasty

Interventions

Cemented or uncemented total hip arthroplasty. No other intervention than observing patients operated according to routine practise at an orthopaedic department.

Lengthening groupRestoration groupshortening group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with unilateral primary osteoarthritis (OA) treated with THA at the orthopaedic department in Sundsvall, Sweden were considered for inclusion.

You may not qualify if:

  • Secondary OA.
  • Previous spinal, pelvic, or lower limb injuries or fractures.
  • Bilateral coxarthrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 24900895BACKGROUND
  • Whitehouse 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.

    PMID: 23507069BACKGROUND
  • McWilliams 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.

    PMID: 23397200BACKGROUND
  • Bertz 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.

    PMID: 22588597BACKGROUND
  • Plaass 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.

    PMID: 21818744BACKGROUND
  • O'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.

    PMID: 21157756BACKGROUND
  • Mahmood 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.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2014

First Posted

October 27, 2014

Study Start

September 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 29, 2015

Record last verified: 2015-10