Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement

Osteoarthritis Clinical Trial

— RTHA and THA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229293
• Other study ID #: VF20050133-2
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2010
• Last updated: September 21, 2012
• Start date: February 2007
• Est. completion date: November 2011

Study information

• Verified date: September 2012
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Articular Surface Replacement (ASR)
Articular surface replacement, DePuy, posterolateral approach used
• Standard Total Hip Arthroplasty (THA)
Device: Biomet 28mm

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern Denmark	Ministry of the Interior and Health, Denmark, Odense University Hospital, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

•   Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital