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

ConditionFemoroacetabular Impingement Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-60
SponsorChunBao Li

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perineal Post-Free Traction

    Procedure/Surgery

    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.

  • Perineal Post Traction

    Procedure/Surgery

    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.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Perineal Post-Free TractionExperimental treatment 1 intervention
Group B: Perineal Post TractionActive comparator 1 intervention

Trial outcomes

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.

Time frame
The first day after surgery

Secondary outcomes

1

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
2

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
3

Intraoperative traction time

Intraoperative traction time

Time frame
During surgery (intraoperatively)
4

Preoperative preparation time

Preoperative preparation time

Time frame
Immediately before surgery (preoperatively)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ChunBao Li

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
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