Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial
| Registry | NCT07322705 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 270 (Estimated) |
| Sponsor | ChunBao Li (Other) |
| Conditions | Femoroacetabular Impingement Syndrome |
| Interventions | Perineal Post-Free Traction, Perineal Post Traction (Procedure) |
| Dates | start 2026-03-30, primary completion 2026-09-30 (estimated), completion 2026-12-30 (estimated), first posted 2026-01-07, last updated 2026-08-13 |
| Locations | 10 sites in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Femoroacetabular Impingement Syndrome All trials of Perineal Post-Free Traction All trials of Perineal Post Traction
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Perineal Post-Free Traction | Experimental | Procedure: Perineal Post-Free Traction | |
| Perineal Post Traction | Active comparator | Procedure: Perineal Post Traction |
Sex: All, ages: 15 Years to 60 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Chinese PLA General Hospital | Beijing, Beijing Municipality | China | Recruiting |
| Shenzhen Second People's Hospital | Shenzhen, Guangdong | China | Recruiting |
| Luoyang Orthopedic Traumatological Hospital of Henan | Luoyang, Henan | China | Recruiting |
| The Affiliated Drum Tower Hospital, Medical School of Nanjing University | Nanjing, Jiangsu | China | Recruiting |
| The Second Affiliated Hospital of Air Force Medical University (AFMU) | Xi'an, Shaanxi | China | Recruiting |
| The Second Affiliated Hospital of Shandong First Medical University | Tai’an, Shandong | China | Recruiting |
| Shanghai General Hospital | Shanghai, Shanghai Municipality | China | Recruiting |
| West China Hospital, Sichuan University | Chengdu, Sichuan | China | Recruiting |
| The First Affiliated Hospital of Kunming Medical University | Kunming, Yunnan | China | Recruiting |
| Zhejiang Provincial Hospital of Chinese Medicine | Hangzhou, Zhejiang | China | Recruiting |