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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Articular Surface Replacement (ASR); Procedure: Standard Total Hip Arthroplasty (THA)

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital; The Danish Rheumatism Association; Ministry of the Interior and Health, Denmark
• Investigators: Study Chair: Søren Overgaard, Prof., MD., PhD, Odense University Hospital

Publications and helpful links

General Publications

• Jensen C, Rosenlund S, Nielsen DB, Overgaard S, Holsgaard-Larsen A. The use of the Gait Deviation Index for the evaluation of participants following total hip arthroplasty: An explorative randomized trial. Gait Posture. 2015 Jun;42(1):36-41. doi: 10.1016/j.gaitpost.2015.02.009. Epub 2015 Apr 28.
• 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. doi: 10.1016/j.joca.2011.06.011. Epub 2011 Jun 28.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 25, 2010
• First Submitted That Met QC Criteria: October 26, 2010
• First Posted (Estimate): October 27, 2010

Study Record Updates

• Last Update Posted (Estimate): September 25, 2012
• Last Update Submitted That Met QC Criteria: September 21, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Osteoarthritis; Hip replacement; Muscle strength; Hip arthroplasty; Mechanical muscle function
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: VF20050133-2