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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Orthopaedic department of Køge Hospital
Region Zealand
Region 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
ClinicalTrials.gov Identifier:
NCT01616667
First received: May 30, 2012
Last updated: September 13, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Unilateral Primary Osteoarthritis of Hip
Procedure: Total hip arthroplasty
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month [ Time Frame: Endpoint 12 month ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, 3 month, 6 month and endpoint 12 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Primary study

  • University of California Los Angeles activity score (UCLA), 12 month [ Time Frame: Baseline, 3 month, 6 month and endpoint 12 month ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Primary study


Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Modified direct lateral approach
The patients included is operated with a total hip arthroplasty using a modified direct lateral approach
Procedure: Total hip arthroplasty
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
Procedure: Total hip arthroplasty
The patients included is operated with a total hip arthroplasty due to primary osteoarthritis

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616667

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000 C
Sponsors and Collaborators
Odense University Hospital
Orthopaedic department of Køge Hospital
Region Zealand
Region Southern Denmark
University of Southern Denmark
The Danish Rheumatism Association
Bevica Fonden
Bjarne Jensens Fond
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
  More Information

No publications provided

Responsible Party: Signe Rosenlund, MD, ph.d. student, MD, ph.d.-student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01616667     History of Changes
Other Study ID Numbers: S-20120009, A2116 Signe Rosenlund, 11/28589
Study First Received: May 30, 2012
Last Updated: September 13, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark:The Regional Committee on Biomedical Research Ethic

Keywords provided by Odense University Hospital:
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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014