Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA (COMPALA)

June 3, 2015 updated by: Signe Rosenlund, MD, ph.d. student, Odense University Hospital

Posterior Approach Versus Lateral Approach in Osteoarthritis Patients, With Primary Total Hip Arthroplasty. The Effect on Early Physical Function, Pain, Patient Reported Outcome Measures, Gait and Muscle Weakness A Randomized Clinical Trial

The aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. The main study investigates the patient-reported outcome measures (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the level of physical function and pain within the first 3 month after surgery, and ii) investigate the potential difference the two approaches have on gait-patterns and maximal isometric hip-muscle-strength, within the first year after surgery. Both approaches are described with potential drawbacks. Posterior approach has a higher risk of dislocation of the prostheses and revision due to dislocation compared with Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of pain, lower physical function, gait abnormalities and muscle weakness, leading to less satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more investigation is needed to determine the extent of differences.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Odense, Denmark, 5000 C
        • Odense University Hospital

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

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 45-70 years, both included.
  • Patients schedule for primary cementless total hip arthroplasty.
  • Endstage hip osteoarthritis(OA) or minor dysplasia of the hip(CE-angle > 20 degrees).

Exclusion Criteria:

  1. more major joint (hip or knee) than the current hip affected with OA, with expected joint replacement surgery within a year.
  2. Prior joint replacement surgery on any major joint (hip, knee) in lower limb.
  3. BMI above 35.
  4. Any physical disability that prevents patients from walking 20 meters without aid.
  5. The patients is not suitable for standard cementless prosthetic components.
  6. Any neurological disease (ex. cerebral thrombosis, Parkinson) compromising the walking ability.
  7. Any severe medical condition compromising walking ability (ex. chronic heart failure, chronic obstructive pulmonary disease).
  8. Severe dementia.
  9. Inability to read and understand Danish writing and oral instructions.
  10. Do not want to participate

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Modified direct lateral approach
The patients included is operated with a total hip arthroplasty using a modified direct lateral approach
The patients included is operated with a total hip arthroplasty due to primary osteoarthritis
Active Comparator: Posterior approach
The patients included is operated with a total hip arthroplasty using posterior approach
The patients included is operated with a total hip arthroplasty due to primary osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month
Time Frame: Endpoint 12 month

Primary study:

Hip Disability and Osteoarthritis Outcome Score (HOOS) includes five subscales: 1)Pain 2) Other symptoms 3) Activities of daily living(ADL) 4) Sport and recreation function and 5) Hip related quality of life. HOOS-Physical Function Short form (HOOS-PS) is an aggregation and shortening of the two original subscales of HOOS-ADL and Sport and Recreation. HOOS-PS is a validated instrument. HOOS has been translated to Danish.

We will use HOOS-PS as primary outcome.

Endpoint 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month
Time Frame: Baseline, 3 month, 6 month and endpoint 12 month
Primary study
Baseline, 3 month, 6 month and endpoint 12 month
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month
Time Frame: Baseline, 3 month, 6 month and endpoint 12 month
Primary study
Baseline, 3 month, 6 month and endpoint 12 month
University of California Los Angeles activity score (UCLA), 12 month
Time Frame: Baseline, 3 month, 6 month and endpoint 12 month

Primary study:

University of California Los Angeles activity score (UCLA) is a score focusing on patient activity level. The score is based on a scale from 1 to 10, ranging from inactive to regularly participate in impact sport or heavy labor. UCLA contributes with important qualitative information with regard to patient activity in correlation with other clinical outcome measures. UCLA is found reliable and valid and is translated to Danish.

Baseline, 3 month, 6 month and endpoint 12 month
EQ-5D self-rated health index -and EQ VAS scores, 12 month
Time Frame: Baseline, 3 month, 6 month and endpoint 12 month

Primary study:

EuroQol/EQ-5D is a standardized, reliable and validated instrument to measure quality of life. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and the EQ VAS that records the respondent's overall self-rated health on a vertical, visual analogue scale. EQ-5D is translated to Danish.

Baseline, 3 month, 6 month and endpoint 12 month
The 20 meter walk-test (20MeWa)
Time Frame: Baseline, 3 days, 21 days and endpoint 3 month

Sub-study 1:

The 20 meter walk-test (20MeWa). Patients are instructed to walk 20 meters between two clearly visible lines marked on the floor. The patients are instructed to walk with their usual pace on two trials and on the two following trials to walk at maximal pace, at which they feel secure. The mean velocity of each two trials are used for further analysis.

Baseline, 3 days, 21 days and endpoint 3 month
"Timed Up and Go"- test (TUG), 3 month
Time Frame: Baseline, 3 days, 21 days and endpoint 3 month

Sub-study 1:

The "Timed Up and Go" test (TUG) measures the time it takes a person to rise from a chair walk 3 meters, turn and walk back to the chair and sit down again. TUG is found to be a reliable and valid test for quantifying functional mobility.

Baseline, 3 days, 21 days and endpoint 3 month
"Repeated chair rise"- test (RCR), 3 month
Time Frame: Baseline, 3 days, 21 days and endpoint 3 month

Sub-study 1:

"Repeated chair rise"- test (RCR) assess the strength of the lower limb muscles overall. The test measures the maximum "stand and sit" cycles the test-person can perform on a chair within in 30 seconds. The test has been showed to gives a reliable and valid measurement of lower body strength in generally active older adults.

Baseline, 3 days, 21 days and endpoint 3 month
30 seconds maximal repeated unilateral knee bending, 3 month
Time Frame: Baseline, 3 days, 21 days and endpoint 3 month

Sub-study 1:

30 seconds maximal repeated unilateral knee bending. It evaluates the maximum number of knee bends performed on one leg in 30 seconds and the ability to execute fast coupled eccentric-concentric muscle force over the knee joint. The patient stand aligned with the front of their foot touching a straight line taped to the floor; finger tip support for balance is provided by the examiner. The patient is then asked to bend the knee, without bending forward from the hip, until he/she could no longer see the line at the toes (about 30º of knee flexion).

Baseline, 3 days, 21 days and endpoint 3 month
Opioid consumption, 3 month
Time Frame: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week

Sub-study 1:

The opioid consumption will be patient administrated and recorded each day, the first 5 days after surgery. After discharged the patient will fill in a patients-diary, where the analgesics consumption are registered.

Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Self-reported pain on a numerical ranking scale(NRS), 3 month
Time Frame: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week

Sub-study 1:

The self-reported pain on a numerical ranking scale(NRS)will be recorded each day, the first 5 days after surgery. After discharged the patient will fill in a patients-diary, where the NRS are registered.

Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 3 month
Time Frame: Baseline, 5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week

Sub-study 1:

We will use the Hip Disability and Osteoarthritis Outcome Score (HOOS)subscales -Pain.

It will be recorded after discharged in a patients-diary

Baseline, 5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Hip Range of motion (ROM), 3 month
Time Frame: Baseline and endpoint 3 month

Sub-study 1:

Range of motion in the hip joint evaluated by goniometer at baseline and 3 month post-surgery Extension/Flexion. Abduction/adduction. Internal/external rotation.

Baseline and endpoint 3 month
Gait Deviation Index(GDI), 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month

Sub-study 2:

Data from 3 dimensional gait analysis(6 camara Vicon MX Motion Analysis system), including EMG analysis during gait.

Gait Deviation Index (GDI) was created to present gaitanalysis data in one score to give a comprehensive evaluation of the patients ambulation compared to healthy subjects. GDI is calculated from 15 kinematic variables, representing 98% of the variation in gait-patterns. A GDI score upon 100 represent normal gait. Every 10 points below this represent 1 standard deviation (SD) from normal gait.

Baseline, 3 month, and endpoint 12 month
Kinematic gait data, 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month

Sub-study 2:

Data from 3 dimensional gait analysis(6 camara Vicon MX Motion Analysis system), including EMG analysis during gait.

Kinematic:

Sagittal hip Range of motion: extension/flexion. Frontal hip Range of motion: abduction/adduction. Frontal trunk inclination: left and right movement of the trunk.

Baseline, 3 month, and endpoint 12 month
Temporospatial parameters, 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month

Sub-study 2:

Data from 3 dimensional gait analysis(6 camara Vicon MX Motion Analysis system), including EMG analysis during gait.

Temporospatial parameters:

Velocity. Cadance. Step duration. Stance duration

Baseline, 3 month, and endpoint 12 month
Electromyography (EMG) during walk, 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month

Sub-study 2:

Data from 3 dimensional gait analysis(6 camara Vicon MX Motion Analysis system), including EMG analysis during gait.

Electromyography (EMG)during walk:

Peak EMG- in stance phase (absolute/normalized to MVC) Mean EMG- in stance phase (absolute/normalized to MVC) Integrated EMG during stancephase

Baseline, 3 month, and endpoint 12 month
Isometric maximal voluntary muscle contraction(MVC), 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month

Sub-study 2:

Data from: Isometric maximal voluntary muscle contraction(MVC), including EMG analysis during test.

Maximal force (Fmax):

Hip Extension Flexion and Abduction. Rate of force development(RFD): Hip Extension. Flexion and Abduction

Baseline, 3 month, and endpoint 12 month
Limping question from Harris Hip Score
Time Frame: Baseline, 3 month, 6 month and endpoint 12 month
Primary study
Baseline, 3 month, 6 month and endpoint 12 month

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Signe Rosenlund, MD, Odense University Hospital and University of Southern Denmark
  • Study Chair: Søren Overgaard, MD, Professor, Odense University Hospital and University of Southern Denmark

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.

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

May 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • S-20120009
  • A2116 Signe Rosenlund (Other Identifier: The Danish Rheumatism Association)
  • 11/28589 (Other Identifier: Region of Southern Denmark)

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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