Clinical trial NCT01229293: Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement
Official title: The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Mechanical muscle function
Muscle strength
Hip replacement
Osteoarthritis
Hip arthroplasty
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Ministry of the Interior and Health, Denmark
name: The Danish Rheumatism Association
name: Odense University Hospital
First posted: 2010-10-27
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Maximal muscle strength (Peak torque, Nm)
timeFrame: 52 wks post-surgery (primary endpoint)
Secondary outcomes:
measure: Rapid force capacity (Rate of torque development, Nm/sec)
timeFrame: 52 wks post-surgery (primary endpoint)
measure: Gait parameters
timeFrame: 26 wks post-surgery (primary endpoint)
measure: Postural Control
timeFrame: 52 wks post-surgery (primary endpoint)
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark
Study officials:
affiliation: Odense University Hospital
name: Søren Overgaard, Prof., MD., PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.