Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?

Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Femoroacetabular Impingement Syndrome
• Intervention / Treatment: Procedure: Perineal Post-Free Traction; Procedure: Perineal Post Traction

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perineal Post-Free Traction	Procedure: Perineal Post-Free Traction; Traction achieved with a thoraco-abdominal belt and contralateral groin strap; operating table tilted 10-15° Trendelenburg; gradual 10-20 kg distraction under fluoroscopy to 8-10 mm joint space. No perineal post is used, eliminating direct perineal pressure.
Active Comparator: Perineal Post Traction	Procedure: Perineal Post Traction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of perineal nerve injury	The incidence of perineal nerve injury included: perineal numbness, pain, soft tissue injury, sexual function and urinary dysfunction.sexual function and urinary dysfunction.	The first day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of pain, numbness, soft tissue injury in other places	Lower limb ankle numbness and soft tissue injury; the contralateral groin pain, numbness and soft tissue injury; chest pain, numbness, soft tissue injury with fixed place	The first day after surgery
Patients at discharge perineum area incidence of nerve injury	Patients at discharge perineum area incidence of nerve injury include: perineum area numbness, pain, soft tissue injuries, sexual and urinary dysfunction.	7 days after surgery
Intraoperative traction time	Intraoperative traction time	During surgery (intraoperatively)
Preoperative preparation time	Preoperative preparation time	Immediately before surgery (preoperatively)
Operating time	Operating time	During surgery (intraoperatively)
The average length of hospital stay after surgery	The average length of hospital stay after surgery	6 weeks after surgery
Postoperative joint function assessment	Visual Analog Scale (VAS) (range 0-10; higher scores indicate worse outcomes).	3 months after surgery
Postoperative joint function assessment	Modified Harris Hip Score (mHHS) (range 0-100; higher scores indicate better outcomes).	3 months after surgery
Postoperative joint function assessment	Hip Outcome Score (HOS) (range 0%-100%; higher scores indicate better outcomes).	3 months after surgery
Economic Evaluation - Pain Intensity	This study will conduct an economic evaluation from a healthcare sector and societal perspective. Pain intensity is assessed using the Visual Analog Scale (VAS), a unidimensional measure reported as scores on a 0-100 mm scale. Effectiveness analysis will incorporate this clinical outcome. Safety will be evaluated by monitoring the incidence of adverse events within 3 months postoperatively.	14 days after surgery
Economic Evaluation - Hip Function	This study will conduct an economic evaluation from a healthcare sector and societal perspective. Hip function is assessed using the modified Harris Hip Score (mHHS), a measure specifically for hip dysfunction and related symptoms, reported as scores on a 0-100 scale. Effectiveness analysis will incorporate this clinical outcome. Safety will be evaluated by monitoring the incidence of adverse events within 3 months postoperatively.	14 days after surgery
Mean Total Healthcare Cost per Patient within 14 Days Postoperatively	This is the cost input measure for the economic evaluation, adopting a healthcare system perspective. All direct medical costs related to the surgery and subsequent care from the day of surgery until 14 days postoperatively will be collected via the Hospital Information System. Costs include fees for surgery, anesthesia, medical supplies, hospitalization, medication, imaging and laboratory tests, and additional costs for managing complications. The mean total cost per patient (in Chinese Yuan, CNY) will be calculated separately for the "conventional perineal-post traction group" and the "perineal-post-free traction group".	Data collection period: From randomization until 14 days postoperatively.

Collaborators and Investigators

• Sponsor: ChunBao Li

Study record dates

Study Major Dates

• Study Start (Estimated): January 7, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Pathological Conditions, Signs and Symptoms; Femoracetabular Impingement
• Other Study ID Numbers: 2024KY0158-KS001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No