Femoroacetabular Impingement SyndromeNCT07322705
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
A study testing Perineal Post-Free Traction and Perineal Post Traction in people with Femoroacetabular Impingement Syndrome, run by ChunBao Li at 10 sites in China.
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Femoroacetabular Impingement Syndrome
- What is being tested?
- Perineal Post-Free Traction and Perineal Post Traction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 10 sitesChina
- Study dates
- 30 Mar 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100143
Chunbao Li, MD, 010-66938206, lichunbao301@163.com
Long Wang, MD, 010-66848954, longwangbj@163.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Gang Chen, MD, 7422979@qq.com
Xue Zhang, 2742870675@qq.com
- Recruiting
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310006
Guoqian Chen, MD, 944583962@qq.com
Ying Zhong, 13656718488@vip.163.com
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Di Jia, MD, 514697915@qq.com
Wen Wen, 360936365@qq.com
- Recruiting
Luoyang Orthopedic Traumatological Hospital of Henan
Luoyang, Henan, 471002
Liyun Liu, MD, liuliyunbs@126.com
Huayu Fan, huayulyzg@163.com
- Recruiting
The Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
Zhihong Xu, MD, xuzhihongjoint@hotmail.com
Zhengyuan Bao, brandonbao@link.cuhk.edu.hk
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Shanxing Zhang, MD, zhangshanxing1984@163.com
Jiwu Chen, MD, jeevechen@gmail.com
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Kan Ouyang, MD, 337395691@qq.com
Yongkang Yang, uniballken@icloud.com
- Recruiting
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000
Qingfeng Yin, MD, geoffreyin84@163.com
Yi Liu, liuyiys@163.com
- Recruiting
The Second Affiliated Hospital of Air Force Medical University (AFMU)
Xi'an, Shaanxi, 710038
Zhixue Wang, MD, 13630212103@163.com
Zhichen Zou, doctor_zhichenzou@163.com
About this study
Official title: Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial
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.
Read more
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
- Conditions
- Femoroacetabular Impingement Syndrome
- Being tested
- Perineal Post-Free Traction, Perineal Post Traction
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal Post-Free TractionProcedure or surgery
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 TractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Perineal Post-Free Traction | Experimental | Not described Receives: Procedure: Perineal Post-Free Traction |
| Perineal Post Traction | Active comparator | Not described Receives: Procedure: Perineal Post Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of perineal nerve injury
The incidence of perineal nerve injury included: perineal numbness, pain, soft tissue injury, sexual function and urinary dysfunction.
Measured: The first day after surgery
Secondary outcomes (13)
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
Measured: The first day after surgery
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.
Measured: 7 days after surgery
Intraoperative traction time
Intraoperative traction time
Measured: During surgery (intraoperatively)
Preoperative preparation time
Preoperative preparation time
Measured: Immediately before surgery (preoperatively)
Operating time
Operating time
Measured: During surgery (intraoperatively)
The average length of hospital stay after surgery
The average length of hospital stay after surgery
Measured: 6 weeks after surgery
Postoperative joint function assessment
Visual Analog Scale (VAS) (range 0-10; higher scores indicate worse outcomes).
Measured: 3 months after surgery
Postoperative joint function assessment
Modified Harris Hip Score (mHHS) (range 0-100; higher scores indicate better outcomes).
Measured: 3 months after surgery
Postoperative joint function assessment
Hip Outcome Score (HOS) (range 0%-100%; higher scores indicate better outcomes).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Data collection period: From randomization until 14 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start30 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChunBao Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ChunBao Li, Chinese PLA General Hospital
- Investigators
- chunbao li, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322705
- Sponsor's protocol ID
- 2024KY0158-KS001
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Wang L, Zhang L, Wang Y, Wang M, Zheng L, Zhang J, Wu Y, Liu Y, Jiang L, Kang X, Li C. Multicentre randomised controlled trial protocol in China comparing postless hip arthroscopy with conventional perineal post-assisted hip arthroscopy to reduce perineal complications in patients undergoing hip arthroscopy for femoroacetabular impingement: the POSTLESS-HIP trial. BMJ Open. 2026 Sep 28;16(9):e118402. doi: 10.1136/bmjopen-2026-118402.
PubMed 42805650
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07322705
- Acronym / sponsor ID
- 2024KY0158-KS001
- Conditions
- Femoroacetabular Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- ChunBao LiUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal Post-Free Traction | Experimental | Procedure: Perineal Post-Free Traction |
| Perineal Post Traction | Active comparator | Procedure: Perineal Post Traction |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal Post-Free TractionTraction 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 or surgery | Perineal Post-Free Traction |
| Perineal Post TractionStandard 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. | Procedure or surgery | Perineal Post Traction |
Primary outcome
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.
13 secondary outcomes
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
Mean Total Healthcare Cost per Patient within 14 Days Postoperatively
Time frame: Data collection period: From randomization until 14 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 42805650Wang L, Zhang L, Wang Y, Wang M, Zheng L, Zhang J, Wu Y, Liu Y, Jiang L, Kang X, Li C. Multicentre randomised controlled trial protocol in China comparing postless hip arthroscopy with conventional perineal post-assisted hip arthroscopy to reduce perineal complications in patients undergoing hip arthroscopy for femoroacetabular impingement: the POSTLESS-HIP trial. BMJ Open. 2026 Sep 28;16(9):e118402. doi: 10.1136/bmjopen-2026-118402.
- Individual participant dataSharing planned: 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.
Related trials for Femoroacetabular Impingement Syndrome
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)
Active, not recruiting
Early Feasibility Study of Cartilage Defect Repair
Osteoarthritis, Hip, Femoroacetabular Impingement
Not yet recruiting
Labral Repair vs Reconstruction
Femoral Acetabular Impingement
Not yet recruiting
3D MRI Assessment of Femoroacetabular Impingement in Patients With ACL Rupture - Exploratory Study
Femoroacetabular Impingement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
chunbao li, MD principal investigator
Chinese PLA General Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal Post-Free Traction and Perineal Post Traction in people with Femoroacetabular Impingement Syndrome, run by ChunBao Li at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chunbao li, MD (+86-010-66938206, lichunbao301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of perineal nerve injury (time frame: The first day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07322705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.