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NCT Number: NCT07322705

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

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

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Key information

Conditions

Femoroacetabular Impingement Syndrome Femoracetabular Impingement Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Jishuitan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perineal Post-Free Traction

Procedure

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

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

    Time frame: The first day after surgery

    The incidence of perineal nerve injury included: perineal numbness, pain, soft tissue injury, sexual function and urinary dysfunction.

Secondary outcomes

  1. The incidence of pain, numbness, soft tissue injury in other places

    Time frame: The first day after surgery

    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

  2. Patients at discharge perineum area incidence of nerve injury

    Time frame: 7 days after surgery

    Patients at discharge perineum area incidence of nerve injury include: perineum area numbness, pain, soft tissue injuries, sexual and urinary dysfunction.

  3. Intraoperative traction time

    Time frame: During surgery (intraoperatively)

    Intraoperative traction time

  4. Preoperative preparation time

    Time frame: Immediately before surgery (preoperatively)

    Preoperative preparation time

  5. Operating time

    Time frame: During surgery (intraoperatively)

    Operating time

  6. The average length of hospital stay after surgery

    Time frame: 6 weeks after surgery

    The average length of hospital stay after surgery

  7. Postoperative joint function assessment

    Time frame: 3 months after surgery

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

  8. Postoperative joint function assessment

    Time frame: 3 months after surgery

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

  9. Postoperative joint function assessment

    Time frame: 3 months after surgery

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

  10. Postoperative joint function assessment

    Time frame: 3 months after surgery

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

  11. Economic Evaluation - Pain Intensity

    Time frame: 14 days after surgery

    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.

  12. Economic Evaluation - Hip Function

    Time frame: 14 days after surgery

    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.

  13. Mean Total Healthcare Cost per Patient within 14 Days Postoperatively

    Time frame: Data collection period: From randomization until 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".

Study contacts

Contact information is provided by the study sponsor or research team.

chunbao li, MD

CONTACT

[email protected]

+86-010-66938206

long wang, MD

CONTACT

[email protected]

+86-010-66848954

Sponsors and collaborators

Lead sponsor

ChunBao Li

Other

Registry information

Official study title

Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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