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

University of Southern Denmark (SDU) logo

University of Southern Denmark (SDU)

Status and phase

Completed
Phase 2

Conditions

Osteoarthritis

Treatments

Procedure: Articular Surface Replacement (ASR)
Procedure: Standard Total Hip Arthroplasty (THA)

Study type

Interventional

Funder types

Other

Identifiers

NCT01229293
VF20050133-2

Details and patient eligibility

About

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.

Full 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

Enrollment

39 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

39 participants in 2 patient groups

Resurfacing Total Hip Arthroplasty
Experimental group
Description:
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)
Treatment:
Procedure: Articular Surface Replacement (ASR)
Standard Total Hip Arthroplasty (THA)
Active Comparator group
Description:
A standard 28 mm head uncemented THA
Treatment:
Procedure: Standard Total Hip Arthroplasty (THA)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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