Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery for FFP3-4 Fragility Fractures of the Pelvis in Elderly Patients
9. Juni 2026 aktualisiert von: Junbo Liang
Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery in Elderly Patients With FFP3-4 Fragility Fractures of the Pelvis
This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conventional surgery in elderly patients with FFP3-4 fragility fractures of the pelvis.
Eligible patients will be stratified according to FFP 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, perioperative complications, venous thromboembolism events, laboratory parameters, imaging outcomes, and healthcare resource utilization.
The study aims to provide evidence for optimizing surgical treatment strategies in elderly patients with unstable pelvic fragility fractures.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted minimally invasive treatment versus conventional surgery in elderly patients with FFP3-4 fragility fractures of the pelvis.
A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conventional surgery group. Randomization will be stratified according to FFP classification (FFP3 or FFP4) using a computer generated randomization sequence.
Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP3 or FFP4 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, venous thromboembolism events, laboratory parameters, complications, opioid consumption, and healthcare resource utilization between treatment strategies.
Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic 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, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, 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 elderly patients with unstable pelvic fragility fractures.
Studientyp
Interventionell
Einschreibung (Geschätzt)
88
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Junbo Liang
- Telefonnummer: 0576-85190463
- E-Mail: lingjb@enzemed.com
Studienorte
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Zhejiang
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Linhai, Zhejiang, China, 317000
- No. 150 Ximen Road
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Kontakt:
- Junbo Liang
- Telefonnummer: 0576-85190463
- E-Mail: liangjb@enzemed.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Age ≥ 60 years
- Low energy trauma
- Diagnosis of osteoporosis
- Diagnosis of FFP3 or FFP4 fragility fractures of the pelvis
- 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Robot Assisted Minimally Invasive Treatment Group
Participants undergo robot assisted minimally invasive fixation for FFP3-4 fragility fractures of the pelvis using robotic navigation assisted percutaneous screw placement.
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Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fragility fractures.
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Aktiver Komparator: Conventional Surgery Group
Participants undergo conventional open surgical fixation for FFP3-4 fragility fractures of the pelvis.
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Conventional open reduction and internal fixation for FFP3-4 pelvic fragility fractures performed without robotic assistance.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Visual Analog Scale (VAS) for Pain
Zeitfenster: 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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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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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EuroQol 5-Dimension 3-Level Questionnaire
Zeitfenster: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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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)
Zeitfenster: 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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Complication
Zeitfenster: From treatment initiation to 1 year follow up
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From treatment initiation to 1 year follow up
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Fracture Healing
Zeitfenster: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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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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Opioid Consumption
Zeitfenster: Time Frame: Postoperative Days 0-3
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Assessment of cumulative opioid consumption during hospitalization
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Time Frame: Postoperative Days 0-3
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Serum C-Reactive Protein Level
Zeitfenster: Time Frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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Time Frame: 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
Zeitfenster: Time Frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
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Time Frame: 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
Zeitfenster: perioperative
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Duration of surgery measured in minutes.
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perioperative
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Intraoperative Blood Loss
Zeitfenster: 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
Zeitfenster: perioperative
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Length of skin incision measured in centimeters.
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perioperative
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Zong Y, Li J, Li Z, Wang W. Minimally invasive surgery and conservative treatment achieve similar clinical outcomes in patients with type II fragility fractures of the pelvis. J Orthop Surg Res. 2025 Feb 27;20(1):210. doi: 10.1186/s13018-025-05581-x.
- Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S. Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010 Mar 16;152(6):380-90. doi: 10.7326/0003-4819-152-6-201003160-00008.
- Banierink H, Ten Duis K, de Vries R, Wendt K, Heineman E, Reininga I, IJpma F. Pelvic ring injury in the elderly: Fragile patients with substantial mortality rates and long-term physical impairment. PLoS One. 2019 May 28;14(5):e0216809. doi: 10.1371/journal.pone.0216809. eCollection 2019.
- Yamamoto N, Someko H, Nakashima Y, Nakao S, Kaneko T, Tsuge T. Mortality following fragility fractures of the pelvis: Systematic review and meta-analysis. Injury. 2025 Oct;56(10):112618. doi: 10.1016/j.injury.2025.112618. Epub 2025 Jul 21.
- Nakayama Y, Suzuki T, Kurozumi T, Watanabe Y. Progression to Rommens type IIIa fragility fracture of the pelvis managed by delayed open reduction and interdigitating screw fixation: A case report. Trauma Case Rep. 2023 Jan 13;43:100773. doi: 10.1016/j.tcr.2023.100773. eCollection 2023 Feb.
- Rommens PM, Arand C, Hopf JC, Mehling I, Dietz SO, Wagner D. Progress of instability in fragility fractures of the pelvis: An observational study. Injury. 2019 Nov;50(11):1966-1973. doi: 10.1016/j.injury.2019.08.038. Epub 2019 Aug 27.
- Jiang Y, Qi X, Cui H, Huang Y, Lv Y, Yang Y, Yao X, Yang D. The Inflammation-Energy Metabolism Axis: A Central Driver of Sarcopenia-Osteoporosis: A Narrative Review. Calcif Tissue Int. 2026 Jan 7;117(1):9. doi: 10.1007/s00223-025-01473-8.
- Rommens PM, Arand C, Hofmann A, Wagner D. When and How to Operate Fragility Fractures of the Pelvis? Indian J Orthop. 2019 Jan-Feb;53(1):128-137. doi: 10.4103/ortho.IJOrtho_631_17.
- Ali KA, He L, Li W, Zhang W, Huang H. Sleep quality and psychological health in patients with pelvic and acetabulum fractures: a cross-sectional study. BMC Geriatr. 2024 Apr 4;24(1):314. doi: 10.1186/s12877-024-04929-y.
- Hutchings L, Roffey DM, Lefaivre KA. Fragility Fractures of the Pelvis: Current Practices and Future Directions. Curr Osteoporos Rep. 2022 Dec;20(6):469-477. doi: 10.1007/s11914-022-00760-9. Epub 2022 Nov 7.
- GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.
- Hitchener WR, Cenedella RJ. Absolute rates of sterol synthesis estimated from [3H]water for bovine lens epithelial cells in culture. J Lipid Res. 1985 Dec;26(12):1455-63.
- Lau-Ting C. Asymptomatic hepatitis B antigen(s) carriers in Singapore: serological reassessment. Singapore Med J. 1988 Feb;29(1):11-3. No abstract available.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
1. Juni 2027
Studienabschluss (Geschätzt)
30. Dezember 2028
Studienanmeldedaten
Zuerst eingereicht
24. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Juni 2026
Zuerst gepostet (Tatsächlich)
10. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juni 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- K20260303
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