Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perineal Post-Free Traction, Perineal Post Traction.
- Who it may be relevant to
- Registry conditions: Femoroacetabular Impingement Syndrome. Basic parameters: 15 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial
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
Interventions
- Procedure Perineal Post-Free Traction
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. - 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.
Primary outcome measures
- The incidence of perineal nerve injury [Time frame: The first day after surgery]
Secondary outcome measures (12)
- The incidence of pain, numbness, soft tissue injury in other places [Time frame: The first day after surgery]
- Patients at discharge perineum area incidence of nerve injury [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 [Time frame: 3 months after surgery]
- Postoperative joint function assessment [Time frame: 3 months after surgery]
- Postoperative joint function assessment [Time frame: 3 months after surgery]
- Postoperative joint function assessment [Time frame: 3 months after surgery]
- Economic Evaluation - Pain Intensity [Time frame: 14 days after surgery]
- Economic Evaluation - Hip Function [Time frame: 14 days after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 13 centers
- Beijing Jishuitan Hospital, Capital Medical University — Beijing
- Chinese PLA General Hospital — Beijing
- The Second Affiliated Hospital of Chongqing Medical University — Chongqing
- Shenzhen Second People's Hospital — Shenzhen
- Luoyang Orthopedic Traumatological Hospital of Henan — Luoyang
- The Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing
- The Second Affiliated Hospital of Air Force Medical University (AFMU) — Xi'an
- The Second Affiliated Hospital of Shandong First Medical University — Tai’an
- … and 5 more centers
Identifiers
NCT: NCT07322705 · 2024KY0158-KS001