Robot Assisted Treatment Versus Conventional Surgery for Tile B and C Pelvic Fractures
2026年5月30日 更新者：Junbo Liang
Comparing the Efficacy and Safety of Robot Assisted Treatment Versus Conventional Surgery in Patients With Tile B and C Pelvic Fractures
This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures.
Eligible patients will be stratified according to Tile fracture classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or conventional surgical treatment.
Primary and secondary outcomes include pain relief, early mobilization, functional recovery, imaging outcomes, perioperative complications, venous thromboembolism events, laboratory parameters, opioid consumption, and healthcare resource utilization.
The study aims to provide evidence for optimizing surgical treatment strategies for unstable pelvic fractures.
調査の概要
詳細な説明
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures.
A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted treatment group or the conventional surgery group. Randomization will be stratified according to Tile fracture classification (Tile B or Tile C) using a computer generated randomization sequence.
Eligible participants include adult patients diagnosed with Tile B or Tile C pelvic fractures within 3 weeks after injury. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, complications, opioid consumption, and healthcare resource utilization between treatment strategies.
Patients in the robot assisted treatment group will undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement. Patients in the conventional surgery group will undergo standard open surgical fixation according to fracture characteristics and surgeon judgment.
Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture healing, laboratory parameters, venous thromboembolism events, opioid consumption, perioperative indicators, complications, and healthcare costs. Follow up assessments will be performed at postoperative day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year.
The results of this study may provide evidence regarding the optimal surgical treatment strategy for Tile B and C pelvic fractures.
研究の種類
介入
入学 (推定)
88
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Junbo Liang, Dr.
- 電話番号：0576-85190463
- メール：liangjb@enzemed.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of Tile B or Tile C pelvic fracture
- Injury duration less than 3 weeks
- Ability to provide written informed consent
Exclusion Criteria:
- Severe open injury or skin infection at the surgical site
- Hemodynamic instability preventing anesthesia or surgery
- Severe psychiatric disorders or dementia
- Severe obesity affecting imaging quality
- Severe systemic diseases preventing surgery
- Pathological fracture
- Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：Robot Assisted Treatment Group
Participants undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement for Tile B and C pelvic fractures.
|
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures.
|
|
アクティブコンパレータ：Conventional Surgery Group
Participants undergo conventional open surgical fixation for Tile B and C pelvic fractures.
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Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures.
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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 |
|---|---|---|
|
Visual Analog Scale (VAS) for Pain
時間枠：At 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Visual Analog Scale (VAS) for pain.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain severity.
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At 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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Majeed Pelvic Function Score
時間枠：At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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The Majeed Pelvic Function Score is used to evaluate functional recovery after pelvic fracture treatment.
Scores range from 0 to 100, with higher scores indicating better functional outcomes and quality of life.
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At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
EuroQol 5-Dimension 3-Level Questionnaire
時間枠：At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Health related quality of life assessed using the EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L).
The EQ-5D index score ranges from values below 0 (health states considered worse than death) to 1.0 (full health).
Higher scores indicate better health related quality of life.
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At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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Short Musculoskeletal Function Assessment (SMFA)
時間枠：At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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Musculoskeletal function assessed using the 46-item Short Musculoskeletal Function Assessment (SMFA).
Raw questionnaire scores are transformed to a standardized score ranging from 0 to 100.
Higher scores indicate worse musculoskeletal function and greater disability.
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At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
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Imaging Outcomes and Fracture Healing
時間枠：At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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Assessment of fracture healing, secondary displacement, bone mineral density changes, and muscle mass changes using pelvic CT and imaging examinations.
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At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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Complication
時間枠：From treatment initiation to 1 year follow up
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From treatment initiation to 1 year follow up
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Opioid Consumption
時間枠：Postoperative Days 0-3
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Assessment of cumulative opioid consumption during hospitalization
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Postoperative Days 0-3
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Serum C-Reactive Protein Level
時間枠：Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
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Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
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D-Dimer Level
時間枠：Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
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Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
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Hemoglobin Level
時間枠：Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
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Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
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Operative Time
時間枠：Perioperative
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Duration of surgery measured in minutes.
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Perioperative
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Intraoperative Blood Loss
時間枠：Perioperative
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Estimated intraoperative blood loss measured in milliliters.
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Perioperative
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Length of Surgical Incision
時間枠：Perioperative
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Length of skin incision measured in centimeters.
|
Perioperative
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Lu Z, Xiuxiu H, Xing B. Retrospective analysis of the use of orthopedic reduction robots in treating low-energy osteoporotic unstable pelvic fractures in the elderly. J Orthop Surg Res. 2025 Sep 26;20(1):844. doi: 10.1186/s13018-025-06258-1.
- Zwingmann J, Konrad G, Kotter E, Sudkamp NP, Oberst M. Computer-navigated iliosacral screw insertion reduces malposition rate and radiation exposure. Clin Orthop Relat Res. 2009 Jul;467(7):1833-8. doi: 10.1007/s11999-008-0632-6. Epub 2008 Nov 26.
- Hoffmann MF, Yilmaz E, Norvel DC, Schildhauer TA. Navigated iliac screw placement may reduce radiation and OR time in lumbopelvic fixation of unstable complex sacral fractures. Eur J Orthop Surg Traumatol. 2021 Oct;31(7):1427-1433. doi: 10.1007/s00590-021-02892-7. Epub 2021 Feb 16.
- Gericke L, Fritz A, Osterhoff G, Josten C, Pieroh P, Hoch A. Percutaneous operative treatment of fragility fractures of the pelvis may not increase the general rate of complications compared to non-operative treatment. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3729-3735. doi: 10.1007/s00068-021-01660-w. Epub 2021 Apr 3.
- Ran D, Wang C. Efficacy and safety of different fixation methods for unstable anterior pelvic ring fractures: a Bayesian network meta-analysis. Ann Med. 2025 Dec;57(1):2563000. doi: 10.1080/07853890.2025.2563000. Epub 2025 Oct 6.
- Lu S, Liu F, Xu W, Zhou X, Li L, Zhou D, Li Q, Dong J. Management of Open Tile C Pelvic Fractures and Their Outcomes: A Retrospective Study of 30 Cases. Ther Clin Risk Manag. 2022 Sep 10;18:929-937. doi: 10.2147/TCRM.S378740. eCollection 2022.
- de Ridder VA, Whiting PS, Balogh ZJ, Mir HR, Schultz BJ, Routt MC. Pelvic ring injuries: recent advances in diagnosis and treatment. OTA Int. 2023 Jun 16;6(3 Suppl):e261. doi: 10.1097/OI9.0000000000000261. eCollection 2023 Jun.
- Tienpratarn W, Nakpipat N, Yuksen C, Wongwaisayawan S, Phootothum Y, Jaiboon S. Clinical Associated Factors of Tile B/C Type of Pelvic Ring Fractures; a Retrospective Cross-sectional study. Arch Acad Emerg Med. 2024 May 12;12(1):e49. doi: 10.22037/aaem.v12i1.2243. eCollection 2024.
- Ding H, Wang W, Sun W, Liu L, Huang M, Han D, Lu Y, Zhou J, Pan J. Clinical characteristics and mortality risk factors in polytrauma patients with pelvic fractures: a retrospective study based on an integrated multidisciplinary treatment approach. Int J Emerg Med. 2025 Oct 6;18(1):192. doi: 10.1186/s12245-025-00990-5.
- Ohla J, Walus P, Wicinski M, Malkowski B, Turon B, Jablonski A, Gawryjolek M, Kellett K, Zabrzynski J. Pelvic Fractures in Adults and the Importance of Associated Injuries-A Current Multi-Disciplinary Approach. Clin Pract. 2025 Jul 11;15(7):130. doi: 10.3390/clinpract15070130.
- Hermans E, Biert J, Edwards MJR. Epidemiology of Pelvic Ring Fractures in a Level 1 Trauma Center in the Netherlands. Hip Pelvis. 2017 Dec;29(4):253-261. doi: 10.5371/hp.2017.29.4.253. Epub 2017 Dec 1.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2028年12月30日
試験登録日
最初に提出
2026年5月24日
QC基準を満たした最初の提出物
2026年5月30日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年5月30日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。