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Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery for FFP3-4 Fragility Fractures of the Pelvis in Elderly Patients

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

88

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Zhejiang
      • Linhai, Zhejiang, Kina, 317000
        • No. 150 Ximen Road
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Robot Assisted Minimally Invasive Fixation
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fragility fractures.
Aktiv komparator: Conventional Surgery Group
Participants undergo conventional open surgical fixation for FFP3-4 fragility fractures of the pelvis.
Procedure: Conventional Open Fixation
Conventional open reduction and internal fixation for FFP3-4 pelvic fragility fractures performed without robotic assistance.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analog Scale (VAS) for Pain
Tidsramme: 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.
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
Majeed Pelvic Function Score
Tidsramme: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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.
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EuroQol 5-Dimension 3-Level Questionnaire
Tidsramme: 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.
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Short Musculoskeletal Function Assessment (SMFA)
Tidsramme: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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.
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Complication
Tidsramme: From treatment initiation to 1 year follow up
From treatment initiation to 1 year follow up
Fracture Healing
Tidsramme: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Opioid Consumption
Tidsramme: Time Frame: Postoperative Days 0-3
Assessment of cumulative opioid consumption during hospitalization
Time Frame: Postoperative Days 0-3
Serum C-Reactive Protein Level
Tidsramme: Time Frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Time Frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Hemoglobin Level
Tidsramme: Time Frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
Time Frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
Operative time
Tidsramme: perioperative
Duration of surgery measured in minutes.
perioperative
Intraoperative Blood Loss
Tidsramme: perioperative
Estimated intraoperative blood loss measured in milliliters.
perioperative
Length of Surgical Incision
Tidsramme: perioperative
Length of skin incision measured in centimeters.
perioperative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Junbo Liang

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

30. december 2028

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • K20260303

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