跳至主要内容
临床试验/NCT06064136
NCT06064136招募中不适用

Psoas Tenotomy Under Ultrasound

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique

研究概览

简要总结

The ilio-psoas conflict is a commonly accepted complication after total hip replacement, often linked to a mispositioning of the acetabular prosthetic component that conflicts with the ilio-psoas tendon. To correct these pains, a psoas tenotomy can be proposed. The results proven by the literature are very satisfactory. Psoas tenotomy is performed endoscopically, arthroscopically, or more rarely open.

The contribution of echo surgery allows to limit the scar ransom but also to free itself from a complex infrastructure to the operating room including an arthroscopy column and an intraoperative fluoroscopy for a conventional tenotomy, This also saves procedural and installation time.

No studies to date have described ultrasound-assisted psoas tenotomy Yhe investigators conducted a cadaveric study of the feasibility of psoas tenotomy under ultrasound that confirms the feasibility of this technique and the safety of the gesture for the surrounding anatomical structures.

The objectives of this study are to assess the feasibility, pain and functional outcomes of ultrasound-assisted psoas tenotomy in patients with ilio-psoas conflict after total hip replacement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique

时间窗: 3 weeks post-operative

The success of this new ultrasound-guided ilio-psoas tendon tenotomy technique will be assessed by the disappearance of the ilio-psoas conflict after surgery. This criterion will be measured at the first control consultation

次要结局

  • Evaluate the installation time(the day of surgery)
  • Evaluate the Forgotten Hip score.(at baseline, 6 weeks, 3 and 6 months post-operative)
  • Evaluate the scarring after surgery(6 weeks post-operative)
  • Evaluate the subjective value of the hip(at baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative)
  • Evaluate the forgotten hip sensation(3 weeks, 6 weeks, 3 and 6 months post-operative)
  • Evaluate the Harris Hip Score(At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative)
  • Evaluate the impact of the patient's quality of life(At baseline, 6 weeks, 3 and 6 months post-operative)
  • Evaluate the patient satisfaction with the results of the operation(3 weeks, 6 weeks, 3 and 6 months post-operative)
  • Evaluation the Postel and Merle Aubigne score(At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative)
  • Evaluate the technical difficulty of surgical procedure(the day after surgery)
  • Evaluate the operative time(the day of surgery)
  • Evaluate the total blood loss(in the month before surgery and the day after surgery)
  • Evaluate the new ultrasound-guided ilio-psoas tendon tenotomy technique compared to standard practice on pain experienced by the patient(Pre-operative, 3 hours, 1 day, 3 weeks, 6 weeks, 3 and 6 months post-operative)
  • Evaluate the Oxford Hip Score(At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative)
  • Evaluate the length of hospital stay(the day after surgery)
  • Evaluate the early (< 90 days) and late (> 90 days) surgical complications related to surgery(During 6 months after surgery)
  • Evaluate the rate of patient requiring a stay in a rehabilitation center(During 6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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