Kann perineumstangenfreie Traktion in der Hüftarthroskopie perineale Komplikationen wirksam reduzieren?
Kann perineumpfostenfreie Traktion in der Hüftarthroskopie perineale Komplikationen wirksam reduzieren? Eine multizentrische prospektive randomisierte kontrollierte Studie
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100143
- Chinese PLA General Hospital
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Guangdong
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Shenzhen, Guangdong, China, 518035
- Shenzhen Second People's Hospital
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Henan
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Luoyang, Henan, China, 471002
- Luoyang Orthopedic Traumatological Hospital of Henan
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- The Affiliated Drum Tower Hospital, Medical School of Nanjing University
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Shaanxi
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Xi'an, Shaanxi, China, 710038
- The Second Affiliated Hospital of Air Force Medical University (AFMU)
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Shandong
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Tai’an, Shandong, China, 271000
- The Second Affiliated Hospital of Shandong First Medical University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200080
- Shanghai General Hospital
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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Yunnan
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Kunming, Yunnan, China, 650032
- The First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- Zhejiang Provincial Hospital of Chinese Medicine
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Perinealfreier Zug
|
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. |
|
Aktiver Komparator: Perineale Zugkraft
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The incidence of perineal nerve injury
Zeitfenster: The first day after surgery
|
The incidence of perineal nerve injury included: perineal numbness, pain, soft tissue injury, sexual function and urinary dysfunction. |
The first day after surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The incidence of pain, numbness, soft tissue injury in other places
Zeitfenster: 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 |
The first day after surgery
|
|
Patients at discharge perineum area incidence of nerve injury
Zeitfenster: 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. |
7 days after surgery
|
|
Intraoperative traction time
Zeitfenster: During surgery (intraoperatively)
|
Intraoperative traction time |
During surgery (intraoperatively)
|
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Preoperative preparation time
Zeitfenster: Immediately before surgery (preoperatively)
|
Preoperative preparation time |
Immediately before surgery (preoperatively)
|
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Operating time
Zeitfenster: During surgery (intraoperatively)
|
Operating time |
During surgery (intraoperatively)
|
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The average length of hospital stay after surgery
Zeitfenster: 6 weeks after surgery
|
The average length of hospital stay after surgery |
6 weeks after surgery
|
|
Postoperative joint function assessment
Zeitfenster: 3 months after surgery
|
Visual Analog Scale (VAS) (range 0-10; higher scores indicate worse outcomes). |
3 months after surgery
|
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Postoperative joint function assessment
Zeitfenster: 3 months after surgery
|
Modified Harris Hip Score (mHHS) (range 0-100; higher scores indicate better outcomes). |
3 months after surgery
|
|
Postoperative joint function assessment
Zeitfenster: 3 months after surgery
|
Hip Outcome Score (HOS) (range 0%-100%; higher scores indicate better outcomes). |
3 months after surgery
|
|
Postoperative joint function assessment
Zeitfenster: 3 months after surgery
|
International Hip Outcome Tool 12-Item Questionnaire (iHOT-12), range 0-100, higher scores mean better hip function |
3 months after surgery
|
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Economic Evaluation - Pain Intensity
Zeitfenster: 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. |
14 days after surgery
|
|
Economic Evaluation - Hip Function
Zeitfenster: 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. |
14 days after surgery
|
|
Mean Total Healthcare Cost per Patient within 14 Days Postoperatively
Zeitfenster: 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". |
Data collection period: From randomization until 14 days postoperatively.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: chunbao li, MD, Chinese PLA General Hospital
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2024KY0158-KS001
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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