Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
研究概览
简要总结
The purpose of our study is to evaluate the differences in functional activities and proprioception after surgery in subjects who underwent hip prosthesis implant with capsulotomy or capsulectomy.
详细描述
Concerning hip arthroplasty surgery, in patients affected by coxarthrosis, there are two different techniques: one is capsulectomy and the second one is capsulotomy with repairing the capsule at the end of the procedure. Both preserving and excising the capsule are accepted methods and the choice whether repairing the capsule or not is up to the surgeon, since studies have not yet demonstrated the superiority of one of the two techniques. Articular capsule has a physiological role in joint stability and proprioception. The presence of proprioceptive nerve endings in hip joint capsule has been observed both in healthy patients and in those affected by coxarthrosis.
If capsulectomy is performed during primary hip arthroplasty, the pseudocapsule that is formed in place of the native capsule will not have any active neurophysiological role in the hip.
For this reason, investigators compare the two surgical techniques with the purpose of highlighting, if existing, the superiority of one technique on the other in terms of better functional recovery and proprioceptive sensibility.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective unilateral primary hip prosthesis utilizing direct anterior approach
- •Signature of the informed consent
排除标准
- •Documented peripheral neuropathies
- •Documented central nervous system diseases that may compromise the balance and/or proprioception
- •Presence of other joint prosthesis in the lower limbs
- •Revision hip arthroplasty
- •Symptomatic osteoarthritis of other joints in the lower limbs (including the controlateral hip) or the spine
- •BMI > 35
- •Systemic diseases or clinical conditions that could interfere with the clinical study
- •Neuromuscular diseases
结局指标
主要结局
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
时间窗: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
次要结局
- Change in Six minutes walk test distance(Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2))
- Change in 30 seconds chair stand test(Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2))
- Hip Proprioception Evaluation Flexion- Measure of the absolute difference between the actual and the subject-replicated target positions.(Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2))
- Hip Proprioception Evaluation Flexion - Measure of the absolute difference between the actual and the subject-replicated target positions.(Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1))
- Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions.(Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2))
- Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions.(Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2))
- Surgical time- minutes(The day of the surgical procedure)
- Percent hemoglobin drop(Up to 2 weeks after surgery (during inpatient stay))
- Active hip Range Of Motion Abduction- degree(Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2))
- Active hip Range Of Motion External Rotation- degree(Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2))
- Active hip Range Of Motion Flexion- degree(Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2))
研究者
Gianfranco Fraschini
MD
IRCCS San Raffaele