- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616667
Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA (COMPALA)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Odense, Denmark, 5000 C
- Odense University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
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
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The patients included is operated with a total hip arthroplasty due to primary osteoarthritis
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Active Comparator: Posterior approach
The patients included is operated with a total hip arthroplasty using posterior approach
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The patients included is operated with a total hip arthroplasty due to primary osteoarthritis
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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
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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
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Baseline, 3 month, 6 month and endpoint 12 month
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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
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EQ-5D self-rated health index -and EQ VAS scores, 12 month
Time Frame: Baseline, 3 month, 6 month and endpoint 12 month
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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
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The 20 meter walk-test (20MeWa)
Time Frame: Baseline, 3 days, 21 days and endpoint 3 month
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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
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"Timed Up and Go"- test (TUG), 3 month
Time Frame: Baseline, 3 days, 21 days and endpoint 3 month
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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
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"Repeated chair rise"- test (RCR), 3 month
Time Frame: Baseline, 3 days, 21 days and endpoint 3 month
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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
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30 seconds maximal repeated unilateral knee bending, 3 month
Time Frame: Baseline, 3 days, 21 days and endpoint 3 month
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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
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Opioid consumption, 3 month
Time Frame: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
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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
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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
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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
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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
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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
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Hip Range of motion (ROM), 3 month
Time Frame: Baseline and endpoint 3 month
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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
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Gait Deviation Index(GDI), 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month
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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
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Kinematic gait data, 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month
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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
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Temporospatial parameters, 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month
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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
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Electromyography (EMG) during walk, 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month
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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
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Isometric maximal voluntary muscle contraction(MVC), 12 month
Time Frame: Baseline, 3 month, and endpoint 12 month
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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
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Limping question from Harris Hip Score
Time Frame: Baseline, 3 month, 6 month and endpoint 12 month
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Primary study
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Baseline, 3 month, 6 month and endpoint 12 month
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Collaborators and Investigators
Sponsor
Collaborators
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
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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