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

October 28, 2015 updated by: Sundsvall Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

174

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
shortening group
Shortening group where the operated leg was more than 5mm shorter compared with the contralateral side
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.
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
Cemented or uncemented total hip arthroplasty. No other intervention than observing patients operated according to routine practise at an orthopaedic department.
Lengthening group
The lengthening group where the operated leg became more than 9mm longer compared with the contralateral side.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
WOMAC
Time Frame: 12-15 months
12-15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
EQ-5D
Time Frame: 12-15 months
12-15 months
Visual analogue scale
Time Frame: 12-15 months
12-15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sundsvall Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sarwar-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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