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Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement (RTHA and THA)

This study has been completed.
Sponsor:
Collaborators:
Ministry of the Interior and Health, Denmark
The Danish Rheumatism Association
Odense University Hospital
Information provided by (Responsible Party):
Carsten Jensen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01229293
First received: October 25, 2010
Last updated: September 21, 2012
Last verified: September 2012

October 25, 2010
September 21, 2012
February 2007
March 2010   (final data collection date for primary outcome measure)
Maximal muscle strength (Peak torque, Nm) [ Time Frame: 52 wks post-surgery (primary endpoint) ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01229293 on ClinicalTrials.gov Archive Site
  • Rapid force capacity (Rate of torque development, Nm/sec) [ Time Frame: 52 wks post-surgery (primary endpoint) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Sway analysis (postural control) during two-leg standing, tandem, one-leg standing and during transistion from sit-to-stand.
Same as current
Not Provided
Not Provided
 
Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement
The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail

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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • Procedure: Articular Surface Replacement (ASR)
    Articular surface replacement, DePuy, posterolateral approach used
  • Procedure: Standard Total Hip Arthroplasty (THA)
    Device: Biomet 28mm
  • 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)
    Intervention: Procedure: Articular Surface Replacement (ASR)
  • Active Comparator: Standard Total Hip Arthroplasty (THA)
    A standard 28 mm head uncemented THA
    Intervention: Procedure: Standard Total Hip Arthroplasty (THA)
Jensen C, Aagaard P, Overgaard S. Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty - a randomised clinical trial. Osteoarthritis Cartilage. 2011 Sep;19(9):1108-16. Epub 2011 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
November 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01229293
VF20050133-2
Yes
Carsten Jensen, University of Southern Denmark
University of Southern Denmark
  • Ministry of the Interior and Health, Denmark
  • The Danish Rheumatism Association
  • Odense University Hospital
Study Chair: Søren Overgaard, Prof., MD., PhD Odense University Hospital
University of Southern Denmark
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP