The Influence of Leg Length Discrepancy After Total Hip Arthroplasty on Function and Quality of Life

Osteoarthritis Clinical Trial

— BioHipLLD  

Official title:

The Influence of Leg Length Discrepancy After Total Hip Arthroplasty on Function and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275494
• Other study ID #: Sarwar-2
• Status: Completed
• Phase: N/A
• First received: October 23, 2014
• Last updated: October 28, 2015
• Start date: September 2010
• Est. completion date: April 2013

Study information

• Verified date: October 2015
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.

Exclusion Criteria:

• Secondary OA.

• Previous spinal, pelvic, or lower limb injuries or fractures.

• Bilateral coxarthrosis.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hip Arthroplasty
• Leg Length Difference
• Leg Length Inequality
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

References & Publications (7)

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. — View Citation

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 — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC		12-15 months	No
Secondary	EQ-5D		12-15 months	No
Secondary	Visual analogue scale		12-15 months	No