Clinical trial NCT01616667: Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unilateral Primary Osteoarthritis of Hip
Keywords: 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
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Orthopaedic department of Køge Hospital
name: Region Zealand
name: Region of Southern Denmark
name: University of Southern Denmark
name: The Danish Rheumatism Association
name: Bevica Fonden
name: Bjarne Jensens Fond
First posted: 2012-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month
timeFrame: Endpoint 12 month
Secondary outcomes:
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month
timeFrame: Baseline, 3 month, 6 month and endpoint 12 month
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month
timeFrame: Baseline, 3 month, 6 month and endpoint 12 month
measure: University of California Los Angeles activity score (UCLA), 12 month
timeFrame: Baseline, 3 month, 6 month and endpoint 12 month
measure: EQ-5D self-rated health index -and EQ VAS scores, 12 month
timeFrame: Baseline, 3 month, 6 month and endpoint 12 month
measure: The 20 meter walk-test (20MeWa)
timeFrame: Baseline, 3 days, 21 days and endpoint 3 month
measure: "Timed Up and Go"- test (TUG), 3 month
timeFrame: Baseline, 3 days, 21 days and endpoint 3 month
measure: "Repeated chair rise"- test (RCR), 3 month
timeFrame: Baseline, 3 days, 21 days and endpoint 3 month
measure: 30 seconds maximal repeated unilateral knee bending, 3 month
timeFrame: Baseline, 3 days, 21 days and endpoint 3 month
measure: Opioid consumption, 3 month
timeFrame: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
measure: Self-reported pain on a numerical ranking scale(NRS), 3 month
timeFrame: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 3 month
timeFrame: Baseline, 5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
measure: Hip Range of motion (ROM), 3 month
timeFrame: Baseline and endpoint 3 month
measure: Gait Deviation Index(GDI), 12 month
timeFrame: Baseline, 3 month, and endpoint 12 month
measure: Kinematic gait data, 12 month
timeFrame: Baseline, 3 month, and endpoint 12 month
measure: Temporospatial parameters, 12 month
timeFrame: Baseline, 3 month, and endpoint 12 month
measure: Electromyography (EMG) during walk, 12 month
timeFrame: Baseline, 3 month, and endpoint 12 month
measure: Isometric maximal voluntary muscle contraction(MVC), 12 month
timeFrame: Baseline, 3 month, and endpoint 12 month
measure: Limping question from Harris Hip Score
timeFrame: Baseline, 3 month, 6 month and endpoint 12 month
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital and University of Southern Denmark
name: Signe Rosenlund, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital and University of Southern Denmark
name: Søren Overgaard, MD, Professor
role: STUDY_CHAIR
References:
citation: 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). 2016 Nov;39:91-99. doi: 10.1016/j.clinbiomech.2016.09.011. Epub 2016 Sep 30.
citation: 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.