Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement

Study Overview
=================
Brief Summary
-----------------
This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical Institute, University of Southern Denmark Aim: To evaluate the effect of implant design on postoperative total leg muscle function recovery and gait in hip replacement patients. Design: A prospective randomized controlled clinical trial where patients are randomized into (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks post-surgery.

Detailed Description
-----------------
The project consist of three substudies: Determination of test-retest reliability and agreement of specific mechanical muscle function variables for the patients of interest. Evaluate the effect of implant design on postoperative mechanical muscle recovery Evaluate the effect of implant design on postoperative gait

Official Title
-----------------
The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Articular Surface Replacement (ASR)
* Procedure: Standard Total Hip Arthroplasty (THA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary arthrosis Exclusion Criteria: Osteoporosis, (T-score < 2.5 SD) of proximal femur BMI > 35 Severe acetabulum dysplasia (AP centre edge < 15-20°) Femur anteversion > 25° Severe caput deformity Leg length discrepancy > 1 cm Off-set problems Earlier fracture of the ipsilateral proximal femur Rheumatoid arthritis Neuromuscular or vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resurfacing Total Hip Arthroplasty<br>A hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint. Articular surface replacement ASR, DePuy posterolateral approach used (RTHA) | Procedure: Articular Surface Replacement (ASR)<br>* Articular surface replacement, DePuy, posterolateral approach used<br>|
| Active Comparator: Standard Total Hip Arthroplasty (THA)<br>A standard 28 mm head uncemented THA | Procedure: Standard Total Hip Arthroplasty (THA)<br>* Device: Biomet 28mm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal muscle strength (Peak torque, Nm) | Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral knee extension-flexion (seated), hip extension-flexion, and hip adduction-abduction (standing), respectively. Both the affected (AF) and non-affected (NA) leg | 52 wks post-surgery (primary endpoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid force capacity (Rate of torque development, Nm/sec) | Determined as the mean tangential slope of the torque-time curve in time intervals 0-100ms (RTD100ms), 0-200ms (RTD200ms) and 0-peak (RTD peak) relative to onset of contraction (t = 0ms) | 52 wks post-surgery (primary endpoint) | 
| Gait parameters | Selfselected, matched and maximal speed, limb index, Gait deviation index, Movement profile analysis togeter with tempo- spatial parameters | 26 wks post-surgery (primary endpoint) | 
| Postural Control | Sway analysis (postural control) during two-leg standing, tandem, one-leg standing and during transistion from sit-to-stand. | 52 wks post-surgery (primary endpoint) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical muscle function, Muscle strength, Hip replacement, Osteoarthritis, Hip arthroplasty