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Completed

NCT Number: NCT01229293

Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark

Odense, 5000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Articular Surface Replacement (ASR)

Procedure

Articular surface replacement, DePuy, posterolateral approach used

Standard Total Hip Arthroplasty (THA)

Procedure

Device: Biomet 28mm

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Ministry of the Interior and Health, Denmark
  • Odense University Hospital
  • The Danish Rheumatism Association

Registry information

Official study title

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

Acronym: RTHA and THA

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Oct 27, 2010
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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