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Completed

NCT Number: NCT01616667

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

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.

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Key information

Conditions

Unilateral Primary Osteoarthritis of Hip

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Odense University Hospital

Odense, 5000 C, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Baseline, 3 month, 6 month and endpoint 12 month

    Primary study

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. "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.

  7. "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.

  8. 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).

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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

  17. 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

  18. Limping question from Harris Hip Score

    Time frame: Baseline, 3 month, 6 month and endpoint 12 month

    Primary study

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

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

Registry information

Official study 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

Acronym: COMPALA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2012
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.