Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Articular Surface Replacement (ASR); Procedure: Standard Total Hip Arthroplasty (THA)

• Registration Number: NCT01229293
• Lead Sponsor: University of Southern Denmark

Brief Summary

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.

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2010-03
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Study Completion: 2011-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-21
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resurfacing Total Hip Arthroplasty	Articular Surface Replacement (ASR)	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)
Standard Total Hip Arthroplasty (THA)	Standard Total Hip Arthroplasty (THA)	A standard 28 mm head uncemented THA

Primary Outcome Measures

Name	Time	Method
Maximal muscle strength (Peak torque, Nm)	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

Name	Time	Method
Rapid force capacity (Rate of torque development, Nm/sec)	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	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	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.

Trial Locations

Locations (1)

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