股関節鏡検査における会陰柱不使用牽引は、会陰合併症を効果的に軽減できるか？
ヒップ関節鏡検査における会陰支柱なしの牽引は会陰合併症を効果的に減少させることができるか？多施設前向き無作為化比較試験
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
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100143
- Chinese PLA General Hospital
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Guangdong
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Shenzhen、Guangdong、中国、518035
- Shenzhen Second People's Hospital
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Henan
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Luoyang、Henan、中国、471002
- Luoyang Orthopedic Traumatological Hospital of Henan
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Jiangsu
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Nanjing、Jiangsu、中国、210008
- The Affiliated Drum Tower Hospital, Medical School of Nanjing University
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Shaanxi
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Xi'an、Shaanxi、中国、710038
- The Second Affiliated Hospital of Air Force Medical University (AFMU)
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Shandong
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Tai’an、Shandong、中国、271000
- The Second Affiliated Hospital of Shandong First Medical University
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200080
- Shanghai General Hospital
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Sichuan
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Chengdu、Sichuan、中国、610041
- West China Hospital, Sichuan University
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Yunnan
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Kunming、Yunnan、中国、650032
- The First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou、Zhejiang、中国、310006
- Zhejiang Provincial Hospital of Chinese Medicine
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：会陰支柱なしの牽引
|
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. |
|
アクティブコンパレータ：会陰部牽引
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of perineal nerve injury
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of pain, numbness, soft tissue injury in other places
時間枠：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
時間枠：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
|
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Intraoperative traction time
時間枠：During surgery (intraoperatively)
|
Intraoperative traction time |
During surgery (intraoperatively)
|
|
Preoperative preparation time
時間枠：Immediately before surgery (preoperatively)
|
Preoperative preparation time |
Immediately before surgery (preoperatively)
|
|
Operating time
時間枠：During surgery (intraoperatively)
|
Operating time |
During surgery (intraoperatively)
|
|
The average length of hospital stay after surgery
時間枠：6 weeks after surgery
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The average length of hospital stay after surgery |
6 weeks after surgery
|
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Postoperative joint function assessment
時間枠：3 months after surgery
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Visual Analog Scale (VAS) (range 0-10; higher scores indicate worse outcomes). |
3 months after surgery
|
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Postoperative joint function assessment
時間枠：3 months after surgery
|
Modified Harris Hip Score (mHHS) (range 0-100; higher scores indicate better outcomes). |
3 months after surgery
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Postoperative joint function assessment
時間枠：3 months after surgery
|
Hip Outcome Score (HOS) (range 0%-100%; higher scores indicate better outcomes). |
3 months after surgery
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Postoperative joint function assessment
時間枠：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
時間枠：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
|
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Economic Evaluation - Hip Function
時間枠：14 days after surgery
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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
|
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Mean Total Healthcare Cost per Patient within 14 Days Postoperatively
時間枠：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.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：chunbao li, MD、Chinese PLA General Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2024KY0158-KS001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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