Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement
NCT ID: NCT01229293
Last Updated: 2012-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2007-02-28
2011-11-30
Brief Summary
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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
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* 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Articular Surface Replacement (ASR)
Articular surface replacement, DePuy, posterolateral approach used
Standard Total Hip Arthroplasty (THA)
A standard 28 mm head uncemented THA
Standard Total Hip Arthroplasty (THA)
Device: Biomet 28mm
Interventions
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Articular Surface Replacement (ASR)
Articular surface replacement, DePuy, posterolateral approach used
Standard Total Hip Arthroplasty (THA)
Device: Biomet 28mm
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
40 Years
65 Years
ALL
No
Sponsors
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Ministry of the Interior and Health, Denmark
OTHER_GOV
The Danish Rheumatism Association
OTHER
Odense University Hospital
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Carsten Jensen
PhD-fellow
Principal Investigators
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Søren Overgaard, Prof., MD., PhD
Role: STUDY_CHAIR
Odense University Hospital
Locations
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Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark
Odense, , Denmark
Countries
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References
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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.
Other Identifiers
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VF20050133-2
Identifier Type: -
Identifier Source: org_study_id