The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximal muscle strength (Peak torque, Nm)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary arthrosis
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Articular Surface Replacement (ASR) (Procedure)
Standard Total Hip Arthroplasty (THA)
A standard 28 mm head uncemented THA
干预措施: Standard Total Hip Arthroplasty (THA) (Procedure)
结局指标
主要结局
Maximal muscle strength (Peak torque, Nm)
时间窗: 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
次要结局
- Rapid force capacity (Rate of torque development, Nm/sec)(52 wks post-surgery (primary endpoint))
- Gait parameters(26 wks post-surgery (primary endpoint))
- Postural Control(52 wks post-surgery (primary endpoint))
研究者
Carsten Jensen
PhD-fellow
University of Southern Denmark