NCT07322705RecruitingNot Applicable
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial
ChunBao Li10 sites in 1 country270 target enrollmentStarted: March 30, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 270
- Locations
- 10
- Primary Endpoint
- The incidence of perineal nerve injury
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Perineal Post-Free Traction
Experimental
Intervention: Perineal Post-Free Traction (Procedure)
Perineal Post Traction
Active Comparator
Intervention: Perineal Post Traction (Procedure)
Outcomes
Primary Outcomes
The incidence of perineal nerve injury
Time Frame: The first day after surgery
The incidence of perineal nerve injury included: perineal numbness, pain, soft tissue injury, sexual function and urinary dysfunction.
Secondary Outcomes
- 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.)
Investigators
ChunBao Li
Director of the Department of Sports Medicine
Chinese PLA General Hospital
Study Sites (10)
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