Unilateral Primary Osteoarthritis of Hip Clinical Trial
— COMPALAOfficial 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
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 45 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Odense University Hospital | Odense |
| Lead Sponsor | Collaborator |
|---|---|
| Odense University Hospital | Bevica Fonden, Bjarne Jensens Fond, Orthopaedic department of Køge Hospital, Region of Southern Denmark, Region Zealand, The Danish Rheumatism Association, University of Southern Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
Endpoint 12 month | No |
| Secondary | Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month | Primary study | Baseline, 3 month, 6 month and endpoint 12 month | No |
| Secondary | Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month | Primary study | Baseline, 3 month, 6 month and endpoint 12 month | No |
| Secondary | 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. |
Baseline, 3 month, 6 month and endpoint 12 month | No |
| Secondary | 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. |
Baseline, 3 month, 6 month and endpoint 12 month | No |
| Secondary | 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. |
Baseline, 3 days, 21 days and endpoint 3 month | No |
| Secondary | "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. |
Baseline, 3 days, 21 days and endpoint 3 month | No |
| Secondary | "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. |
Baseline, 3 days, 21 days and endpoint 3 month | No |
| Secondary | 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 30ยบ of knee flexion). |
Baseline, 3 days, 21 days and endpoint 3 month | No |
| Secondary | 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. |
Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week | No |
| Secondary | 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. |
Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week | No |
| Secondary | 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 |
Baseline, 5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week | No |
| Secondary | 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. |
Baseline and endpoint 3 month | No |
| Secondary | 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. |
Baseline, 3 month, and endpoint 12 month | No |
| Secondary | 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. |
Baseline, 3 month, and endpoint 12 month | No |
| Secondary | 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 |
Baseline, 3 month, and endpoint 12 month | No |
| Secondary | 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 |
Baseline, 3 month, and endpoint 12 month | No |
| Secondary | 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 |
Baseline, 3 month, and endpoint 12 month | No |
| Secondary | Limping question from Harris Hip Score | Primary study | Baseline, 3 month, 6 month and endpoint 12 month | No |