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

N/ANot Yet RecruitingNCT07322705

ChunBao Li270 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

270

Conditions

Femoroacetabular Impingement Syndrome

Interventions

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: The first day after surgery

Secondary Outcomes

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

Time frame: 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.

Time frame: 7 days after surgery

Intraoperative traction time

Time frame: During surgery (intraoperatively)

Preoperative preparation time

Time frame: Immediately before surgery (preoperatively)

Operating time

Time frame: During surgery (intraoperatively)

The average length of hospital stay after surgery

Time frame: 6 weeks after surgery

Postoperative joint function assessment

Visual Analog Scale (VAS) (range 0-10; higher scores indicate worse outcomes).

Time frame: 3 months after surgery

Postoperative joint function assessment

Modified Harris Hip Score (mHHS) (range 0-100; higher scores indicate better outcomes).

Time frame: 3 months after surgery

Postoperative joint function assessment

Hip Outcome Score (HOS) (range 0%-100%; higher scores indicate better outcomes).

Time frame: 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.

Time frame: 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.

Time frame: 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".

Time frame: Data collection period: From randomization until 14 days postoperatively.