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

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ClinicalTrials.gov Identifier: NCT01616667
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : June 4, 2015
Sponsor:
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
Information provided by (Responsible Party):
Signe Rosenlund, MD, ph.d. student, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE May 30, 2012
First Posted Date  ICMJE June 12, 2012
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Activities of daily living(ADL), 12 month [ Time Frame: Endpoint 12 month ]
Primary study: We will use the Hip Disability and Osteoarthritis Outcome Score (HOOS). 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 is a validated instrument. HOOS has been translated to Danish. We will use ADL as primary outcome.
Change History Complete list of historical versions of study NCT01616667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2015)
  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month [ Time Frame: Baseline, 3 month, 6 month and endpoint 12 month ]
    Primary study
  • 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
  • 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.
  • 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.
  • 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.
  • "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.
  • "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.
  • 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).
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • Limping question from Harris Hip Score [ Time Frame: Baseline, 3 month, 6 month and endpoint 12 month ]
    Primary study
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month [ Time Frame: Baseline, 3 month, 6 month and endpoint 12 month ]
    Primary study
  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-other symptoms, 12 month [ Time Frame: Baseline, 3 month, 6 month and endpoint 12 month ]
    Primary study
  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-Sport and recreation function, 12 month [ Time Frame: Baseline, 3 month, 6 month and endpoint 12 month ]
    Primary study
  • 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
  • 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.
  • EQ-5D self-rated health index -(using 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.
  • 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.
  • "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.
  • "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.
  • 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).
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-Activities of daily [ Time Frame: Baseline, 3 month and 6 month ]
    Primary study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Unilateral Primary Osteoarthritis of Hip
Intervention  ICMJE Procedure: Total hip arthroplasty
The patients included is operated with a total hip arthroplasty due to primary osteoarthritis
Study Arms  ICMJE
  • Active Comparator: Modified direct lateral approach
    The patients included is operated with a total hip arthroplasty using a modified direct lateral approach
    Intervention: Procedure: Total hip arthroplasty
  • Active Comparator: Posterior approach
    The patients included is operated with a total hip arthroplasty using posterior approach
    Intervention: Procedure: Total hip arthroplasty
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2012)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01616667
Other Study ID Numbers  ICMJE S-20120009
A2116 Signe Rosenlund ( Other Identifier: The Danish Rheumatism Association )
11/28589 ( Other Identifier: Region of Southern Denmark )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Signe Rosenlund, MD, ph.d. student, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE
  • Orthopaedic department of Køge Hospital
  • Region Zealand
  • Region of Southern Denmark
  • University of Southern Denmark
  • The Danish Rheumatism Association
  • Bevica Fonden
  • Bjarne Jensens Fond
Investigators  ICMJE
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
PRS Account Odense University Hospital
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP