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

Primary Purpose

Unilateral Primary Osteoarthritis of Hip

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Total hip arthroplasty

About this trial

This is an interventional treatment trial for Unilateral Primary Osteoarthritis of Hip focused on measuring Controlled Clinical Trial, Operative Surgical Procedures, Treatment Outcome, Pain Measurement, Quality of Life, Questionnaires/standards, Activities of Daily Living, Biomechanics, Gait*, Hip Joint/physiology*, Hip Joint/surgery*, Recovery of Function/physiology

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Modified direct lateral approach

Posterior approach

Arm Description

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 using posterior approach

Outcomes

Primary Outcome Measures

Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 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.

Secondary Outcome Measures

Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month

Primary study

Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month

Primary study

University of California Los Angeles activity score (UCLA), 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.

EQ-5D self-rated health index -and EQ VAS scores, 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.

The 20 meter walk-test (20MeWa)

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.

"Timed Up and Go"- test (TUG), 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.

"Repeated chair rise"- test (RCR), 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.

30 seconds maximal repeated unilateral knee bending, 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).

Opioid consumption, 3 month

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.

Self-reported pain on a numerical ranking scale(NRS), 3 month

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.

Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 3 month

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

Hip Range of motion (ROM), 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.

Gait Deviation Index(GDI), 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.

Kinematic gait data, 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.

Temporospatial parameters, 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

Electromyography (EMG) during walk, 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

Isometric maximal voluntary muscle contraction(MVC), 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

Limping question from Harris Hip Score

Primary study

Full Information

NCT ID

NCT01616667

First Posted

May 30, 2012

Last Updated

June 3, 2015

Sponsor

Odense University Hospital

Collaborators

Orthopaedic department of Køge Hospital, Region Zealand, Region of Southern Denmark, University of Southern Denmark, The Danish Rheumatism Association, Bevica Fonden, Bjarne Jensens Fond

1. Study Identification

Unique Protocol Identification Number

NCT01616667

Brief Title

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

Acronym

COMPALA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Odense University Hospital

Collaborators

Orthopaedic department of Køge Hospital, Region Zealand, Region of Southern Denmark, University of Southern Denmark, The Danish Rheumatism Association, Bevica Fonden, Bjarne Jensens Fond

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unilateral Primary Osteoarthritis of Hip

Keywords

Controlled Clinical Trial, Operative Surgical Procedures, Treatment Outcome, Pain Measurement, Quality of Life, Questionnaires/standards, Activities of Daily Living, Biomechanics, Gait*, Hip Joint/physiology*, Hip Joint/surgery*, Recovery of Function/physiology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modified direct lateral approach

Arm Type

Active Comparator

Arm Description

The patients included is operated with a total hip arthroplasty using a modified direct lateral approach

Arm Title

Posterior approach

Arm Type

Active Comparator

Arm Description

The patients included is operated with a total hip arthroplasty using posterior approach

Intervention Type

Procedure

Intervention Name(s)

Total hip arthroplasty

Intervention Description

The patients included is operated with a total hip arthroplasty due to primary osteoarthritis

Primary Outcome Measure Information:

Title

Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month

Description

Time Frame

Endpoint 12 month

Secondary Outcome Measure Information:

Title

Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month

Description

Primary study

Time Frame

Baseline, 3 month, 6 month and endpoint 12 month

Title

Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month

Description

Primary study

Time Frame

Baseline, 3 month, 6 month and endpoint 12 month

Title

University of California Los Angeles activity score (UCLA), 12 month

Description

Time Frame

Baseline, 3 month, 6 month and endpoint 12 month

Title

EQ-5D self-rated health index -and EQ VAS scores, 12 month

Description

Time Frame

Baseline, 3 month, 6 month and endpoint 12 month

Title

The 20 meter walk-test (20MeWa)

Description

Time Frame

Baseline, 3 days, 21 days and endpoint 3 month

Title

"Timed Up and Go"- test (TUG), 3 month

Description

Time Frame

Baseline, 3 days, 21 days and endpoint 3 month

Title

"Repeated chair rise"- test (RCR), 3 month

Description

Time Frame

Baseline, 3 days, 21 days and endpoint 3 month

Title

30 seconds maximal repeated unilateral knee bending, 3 month

Description

Time Frame

Baseline, 3 days, 21 days and endpoint 3 month

Title

Opioid consumption, 3 month

Description

Time Frame

Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week

Title

Self-reported pain on a numerical ranking scale(NRS), 3 month

Description

Time Frame

Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week

Title

Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 3 month

Description

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

Time Frame

Baseline, 5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week

Title

Hip Range of motion (ROM), 3 month

Description

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.

Time Frame

Baseline and endpoint 3 month

Title

Gait Deviation Index(GDI), 12 month

Description

Time Frame

Baseline, 3 month, and endpoint 12 month

Title

Kinematic gait data, 12 month

Description

Time Frame

Baseline, 3 month, and endpoint 12 month

Title

Temporospatial parameters, 12 month

Description

Time Frame

Baseline, 3 month, and endpoint 12 month

Title

Electromyography (EMG) during walk, 12 month

Description

Time Frame

Baseline, 3 month, and endpoint 12 month

Title

Isometric maximal voluntary muscle contraction(MVC), 12 month

Description

Time Frame

Baseline, 3 month, and endpoint 12 month

Title

Limping question from Harris Hip Score

Description

Primary study

Time Frame

Baseline, 3 month, 6 month and endpoint 12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Signe Rosenlund, MD

Organizational Affiliation

Odense University Hospital and University of Southern Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Søren Overgaard, MD, Professor

Organizational Affiliation

Odense University Hospital and University of Southern Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000 C

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

27721093

Citation

Rosenlund S, Broeng L, Overgaard S, Jensen C, Holsgaard-Larsen A. The efficacy of modified direct lateral versus posterior approach on gait function and hip muscle strength after primary total hip arthroplasty at 12months follow-up. An explorative randomised controlled trial. Clin Biomech (Bristol, Avon). 2016 Nov;39:91-99. doi: 10.1016/j.clinbiomech.2016.09.011. Epub 2016 Sep 30.

Results Reference

derived

PubMed Identifier

25345483

Citation

Rosenlund S, Broeng L, Jensen C, Holsgaard-Larsen A, Overgaard S. The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2014 Oct 27;15:354. doi: 10.1186/1471-2474-15-354.

Results Reference

derived

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

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