NCT07322705招募中不适用
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial
ChunBao Li10 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2026年3月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 10
- 主要终点
- The incidence of perineal nerve injury
研究概览
简要总结
The goal of this clinical trial is to analyze the impact of perineal post-free traction versus traditional perineal post traction on perineal complications in hip arthroscopy. The main question it aims to answer is:
• Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? Researchers will compare the perineal-post-free traction group with the conventional perineal-post traction group to see if the former decreases perineal complications and improves efficiency without compromising surgical outcomes.
Participants will:
- Undergo either perineal-post-free or standard perineal-post traction during hip arthroscopy
- Complete nerve-injury checks on day 1 and at discharge, and hip-function questionnaires (VAS, mHHS, IHOT-12, HOS) at 3 months
- Allow collection of operating times, hospital stay, and direct medical costs for economic analysis
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 15 to 60 years;
- •Met the diagnostic criteria of femoroacetabular impingement syndrome (FAI) and indicated for hip arthroscopy based on patient history, symptoms, signs, physical examination, imaging (pelvic anteroposterior view, frog-leg view, CT 3D reconstruction, MRI), and diagnostic injections;
- •Able to read and sign the informed consent form.
排除标准
- •History of high-energy hip trauma, previous ipsilateral or contralateral hip surgery, avascular necrosis of the femoral head, slipped capital femoral epiphysis, Perthes disease, severe osteoporosis, tumors, acetabular stress fractures, or proliferative or immune hip diseases;
- •Diseases causing groin numbness, foot numbness, sexual dysfunction, urinary dysfunction, skin injuries, perineal injuries, nerve injuries, radicular pain, inner or outer thigh numbness;
- •Abnormal heart, lung, liver, kidney function, severe coagulation disorders, poorly controlled diabetes, judged by the researcher to have an infection risk;
- •Consciousness disorders, psychiatric disorders, or neuromuscular dysfunction affecting lower limb function;
- •Active infection foci (systemic or local infectious lesions);
- •Pregnancy, lactation, or planned pregnancy during the clinical study period;
- •Participation in another clinical trial within the past 3 months;
- •Patients deemed unsuitable for the clinical trial by the researcher for other reasons.
研究组 & 干预措施
Perineal Post-Free Traction
Experimental
干预措施: Perineal Post-Free Traction (Procedure)
Perineal Post Traction
Active Comparator
干预措施: Perineal Post Traction (Procedure)
结局指标
主要结局
The incidence of perineal nerve injury
时间窗: The first day after surgery
The incidence of perineal nerve injury included: perineal numbness, pain, soft tissue injury, sexual function and urinary dysfunction.
次要结局
- Operating time(During surgery (intraoperatively))
- Postoperative joint function assessment(3 months after surgery)
- The incidence of pain, numbness, soft tissue injury in other places(The first day after surgery)
- Patients at discharge perineum area incidence of nerve injury(7 days after surgery)
- Intraoperative traction time(During surgery (intraoperatively))
- Preoperative preparation time(Immediately before surgery (preoperatively))
- The average length of hospital stay after surgery(6 weeks after surgery)
- Economic Evaluation - Pain Intensity(14 days after surgery)
- Economic Evaluation - Hip Function(14 days after surgery)
- Mean Total Healthcare Cost per Patient within 14 Days Postoperatively(Data collection period: From randomization until 14 days postoperatively.)
研究者
ChunBao Li
Director of the Department of Sports Medicine
Chinese PLA General Hospital
研究点 (10)
Loading locations...
相似试验
进行中（未招募）
不适用
PENG vs PHPB for Hip Arthroplasty AnalgesiaPENG BlockHip Arthroplasty, TotalQoR-15Numeric Rating ScalePENG BlockHip Arthroplasty, TotalQoR-15Numeric Rating ScaleNCT07263932Ankara City Hospital Bilkent127
Enrolling By Invitation
不适用
Arthroscopic Anterior Release Versus Discectomy as Treatments for Temporomandibular Joint Disc Displacement With ReductionTMJ - Injury of Meniscus of Temporomandibular JointTMDTMJ - Oral &Maxillofacial SurgeryNCT07297459Karolinska Institutet65
招募中
4 期
Suprainguinal Fascia Iliaca Block With vs Without DexmedetomidinePostoperative Pain ManagementNCT07316166Rhode Island Hospital120
尚未招募
不适用
A Prospective Randomized Clinical Trial Comparing a Fast-Fix-Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Functional, Clinical, and Surgical OutcomesTemporomandibular Joint Internal DerangementNCT07316673Cairo University50
招募中
4 期
Hip Infiltration in Hip Arthroplasty (HiHa) study – a
randomized controlled trialTotal Hip Arthroplasty / THA2023-509109-57-01Reinier Haga Groep Orthopedisch Centrum B.V.120