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

NCT07322705 | Not Yet Recruiting

• 1 other identifier: 2024KY0158-KS001
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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

Conditions

Femoroacetabular Impingement Syndrome

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.sexual function and urinary dysfunction.

  The first day after surgery

Secondary Outcomes (12)

• 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)

Study Arms (2)

Perineal Post-Free Traction

EXPERIMENTAL

Procedure: Perineal Post-Free Traction

Perineal Post Traction

ACTIVE COMPARATOR

Procedure: Perineal Post Traction

Interventions

Perineal Post-Free Traction PROCEDURE

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.

Perineal Post-Free Traction

Perineal Post Traction PROCEDURE

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.

Perineal Post Traction

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• ChunBao Li: lead

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Record last verified: 2025-12