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| Name | Class |
|---|---|
| Ministry of the Interior and Health, Denmark | OTHER_GOV |
| The Danish Rheumatism Association | OTHER |
| Odense University Hospital | OTHER |
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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.
The project consist of three substudies:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resurfacing Total Hip Arthroplasty | Experimental | 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) |
|
| Standard Total Hip Arthroplasty (THA) | Active Comparator | A standard 28 mm head uncemented THA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Articular Surface Replacement (ASR) | Procedure | Articular surface replacement, DePuy, posterolateral approach used |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Gait parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren Overgaard, Prof., MD., PhD | Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25957650 | Derived | 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. | |
| 21749928 | Derived |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Standard Total Hip Arthroplasty (THA) | Procedure | Device: Biomet 28mm |
|
Selfselected, matched and maximal speed, limb index, Gait deviation index, Movement profile analysis togeter with tempo- spatial parameters |
| 26 wks post-surgery (primary endpoint) |
| 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) |
| 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. |