Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
1 other identifier
interventional
270
1 country
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
July 15, 2026
July 1, 2026
6 months
November 17, 2025
July 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of perineal nerve injury
The incidence of perineal nerve injury included: perineal numbness, pain, soft tissue injury, sexual function and urinary dysfunction.
The first day after surgery
Secondary Outcomes (13)
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)
Operating time
During surgery (intraoperatively)
- +8 more secondary outcomes
Study Arms (2)
Perineal Post-Free Traction
EXPERIMENTALPerineal Post Traction
ACTIVE COMPARATORInterventions
Traction achieved with a thoraco-abdominal belt and contralateral groin strap; operating table tilted 10-15° Trendelenburg under fluoroscopy to 8-10 mm joint space. No perineal post is used, eliminating direct perineal pressure.
Standard traction table with padded perineal post placed against the groin providing counter-traction; affected limb distracted under fluoroscopy to 8-10 mm joint space while contralateral limb is abducted.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ChunBao Lilead
Study Sites (13)
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100035, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100143, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Luoyang Orthopedic Traumatological Hospital of Henan
Luoyang, Henan, 471002, China
The Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008, China
The Second Affiliated Hospital of Air Force Medical University (AFMU)
Xi'an, Shaanxi, 710038, China
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin hospital
Tianjin, Tianjin Municipality, 300211, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
chunbao li, MD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Department of Sports Medicine
Study Record Dates
First Submitted
November 17, 2025
First Posted
January 7, 2026
Study Start
March 30, 2026
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared with external independent researchers. The original informed consent only permits internal study team, institutional ethics committee and regulatory authorities to access coded data for trial quality control, without explicit participant consent for sharing de-identified IPD for external secondary research. Full trial protocol, statistical analysis plan and analytic codes are available to eligible researchers for result replication upon reasonable request.