Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement (RTHA and THA)
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|ClinicalTrials.gov Identifier: NCT01229293|
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : September 25, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Articular Surface Replacement (ASR) Procedure: Standard Total Hip Arthroplasty (THA)||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||November 2011|
Experimental: Resurfacing Total Hip Arthroplasty
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)
Articular surface replacement, DePuy, posterolateral approach used
Active Comparator: Standard Total Hip Arthroplasty (THA)
A standard 28 mm head uncemented THA
Procedure: Standard Total Hip Arthroplasty (THA)
Device: Biomet 28mm
- Maximal muscle strength (Peak torque, Nm) [ Time Frame: 52 wks post-surgery (primary endpoint) ]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
- Rapid force capacity (Rate of torque development, Nm/sec) [ Time Frame: 52 wks post-surgery (primary endpoint) ]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)
- Gait parameters [ Time Frame: 26 wks post-surgery (primary endpoint) ]Selfselected, matched and maximal speed, limb index, Gait deviation index, Movement profile analysis togeter with tempo- spatial parameters
- Postural Control [ Time Frame: 52 wks post-surgery (primary endpoint) ]Sway analysis (postural control) during two-leg standing, tandem, one-leg standing and during transistion from sit-to-stand.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229293
|Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark|
|Odense, Denmark, 5000|
|Study Chair:||Søren Overgaard, Prof., MD., PhD||Odense University Hospital|