Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01229293

Acronym

RTHA and THA

Enrollment

Registered

2010-10-27

Start date

2007-02-28

Completion date

2011-11-30

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Mechanical muscle function, Muscle strength, Hip replacement, Osteoarthritis, Hip arthroplasty

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

Interventions

PROCEDUREArticular Surface Replacement (ASR)

Articular surface replacement, DePuy, posterolateral approach used

PROCEDUREStandard Total Hip Arthroplasty (THA)

Device: Biomet 28mm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026