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

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• Femoracetabular Impingement 108

Study arms

• Experimental
  Perineal Post-Free Traction

  Procedure: Perineal Post-Free Traction

• Active comparator
  Perineal Post Traction

  Procedure: Perineal Post Traction

Interventions

• ProcedurePerineal 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.

• ProcedurePerineal 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 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)

5. Operating time

   Operating time

   Time frame: During surgery (intraoperatively)

6. The average length of hospital stay after surgery

   The average length of hospital stay after surgery

   Time frame: 6 weeks after surgery

7. Postoperative joint function assessment

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

   Time frame: 3 months after surgery

8. Postoperative joint function assessment

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

   Time frame: 3 months after surgery

9. Postoperative joint function assessment

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

   Time frame: 3 months after surgery

10. Postoperative joint function assessment

    International Hip Outcome Tool 12-Item Questionnaire (iHOT-12), range 0-100, higher scores mean better hip function

    Time frame: 3 months after surgery

11. 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

12. 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

13. 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.

Individual participant data

Plan to share: No — 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.