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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineal Post-Free Traction | Experimental |
| |
| Perineal Post Traction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The first day after surgery |
| Patients at discharge perineum area incidence of nerve injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chunbao li, MD | Contact | +86-010-66938206 | lichunbao301@163.com | |
| long wang, MD | Contact | +86-010-66848954 | longwangbj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| chunbao li, MD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100035 | China |
Individual participant data (IPD) will not be shared with external independent researchers. The original informed consent only permits internal study team, institutional ethics committee and regulatory authorities to access coded data for trial quality control, without explicit participant consent for sharing de-identified IPD for external secondary research. Full trial protocol, statistical analysis plan and analytic codes are available to eligible researchers for result replication upon reasonable request.
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|
| 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. |
|
Patients at discharge perineum area incidence of nerve injury include: perineum area numbness, pain, soft tissue injuries, sexual and urinary dysfunction. |
| 7 days after surgery |
| Intraoperative traction time | Intraoperative traction time | During surgery (intraoperatively) |
| Preoperative preparation time | Preoperative preparation time | Immediately before surgery (preoperatively) |
| Operating time | Operating time | During surgery (intraoperatively) |
| The average length of hospital stay after surgery | The average length of hospital stay after surgery | 6 weeks after surgery |
| Postoperative joint function assessment | Visual Analog Scale (VAS) (range 0-10; higher scores indicate worse outcomes). | 3 months after surgery |
| Postoperative joint function assessment | Modified Harris Hip Score (mHHS) (range 0-100; higher scores indicate better outcomes). | 3 months after surgery |
| Postoperative joint function assessment | Hip Outcome Score (HOS) (range 0%-100%; higher scores indicate better outcomes). | 3 months after surgery |
| Postoperative joint function assessment | International Hip Outcome Tool 12-Item Questionnaire (iHOT-12), range 0-100, higher scores mean better hip function | 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. | 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. | 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". | Data collection period: From randomization until 14 days postoperatively. |
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100143 | China |
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| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| Shenzhen Second People's Hospital | Recruiting | Shenzhen | Guangdong | 518035 | China |
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| Luoyang Orthopedic Traumatological Hospital of Henan | Recruiting | Luoyang | Henan | 471002 | China |
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| The Affiliated Drum Tower Hospital, Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| The Second Affiliated Hospital of Air Force Medical University (AFMU) | Recruiting | Xi'an | Shaanxi | 710038 | China |
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| The Second Affiliated Hospital of Shandong First Medical University | Recruiting | Tai’an | Shandong | 271000 | China |
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| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Tianjin hospital | Recruiting | Tianjin | Tianjin Municipality | 300211 | China |
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| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
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| Zhejiang Provincial Hospital of Chinese Medicine | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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