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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229293
First Posted: October 27, 2010
Last Update Posted: September 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose

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 Intervention Phase
Osteoarthritis Procedure: Articular Surface Replacement (ASR) Procedure: Standard Total Hip Arthroplasty (THA) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail

Resource links provided by NLM:


Further study details as provided by Carsten Jensen, University of Southern Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 39
Study Start Date: February 2007
Study Completion Date: November 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Denmark
Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Ministry of the Interior and Health, Denmark
The Danish Rheumatism Association
Odense University Hospital
Investigators
Study Chair: Søren Overgaard, Prof., MD., PhD Odense University Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carsten Jensen, PhD-fellow, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01229293     History of Changes
Other Study ID Numbers: VF20050133-2
First Submitted: October 25, 2010
First Posted: October 27, 2010
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Carsten Jensen, University of Southern Denmark:
Mechanical muscle function
Muscle strength
Hip replacement
Osteoarthritis
Hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases