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Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment for Fragility Fractures of the Pelvis Type 1-2 in Elderly Patients (FFP)

3. juni 2026 opdateret af: Junbo Liang

Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment in Elderly Patients With FFP1-2 Fragility Fractures of the Pelvis

This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conservative treatment in elderly patients with FFP1-2 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 standardized conservative treatment. Primary and secondary outcomes include pain relief, functional recovery, fracture progression, venous thromboembolism events, complications, and healthcare resource utilization. The study aims to provide evidence for optimizing treatment strategies in elderly patients with 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 conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis.

A total of 152 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conservative treatment group. Randomization will be stratified according to FFP classification (FFP1 or FFP2) using a computer generated randomization sequence.

Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP1 or FFP2 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare pain control, early weight bearing, functional recovery, fracture progression, venous thromboembolism events, and healthcare resource utilization between treatment strategies.

Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic fixation, while patients in the conservative treatment group will receive standardized nonoperative management including pain control, anticoagulation prophylaxis, rehabilitation, and osteoporosis treatment.

Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture progression and healing, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, opioid consumption, 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 treatment strategy for elderly patients with FFP1-2 pelvic fragility fractures.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

152

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

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 FFP1 or FFP2 fragility fractures of the pelvis Injury duration less than 3 weeks Ability to walk independently or with assistance before injury Ability to provide written informed consent

Exclusion Criteria:

Severe open injury or skin infection at the surgical site Long term bedridden status or severe disability 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 FFP1-2 fragility fractures of the pelvis.
Procedure: Robot Assisted Minimally Invasive Fixation
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures.
Aktiv komparator: Conservative Treatment Group
Participants receive standardized conservative treatment including pain management, rehabilitation, anticoagulation prophylaxis, and osteoporosis treatment.
Procedure: Robot Assisted Minimally Invasive Fixation
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analog Scale (VAS) for Pain
Tidsramme: At 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 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
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
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
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Fracture Progression and Healing
Tidsramme: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Assessment of fracture healing, secondary displacement, and FFP classification progression using pelvic CT.
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
Assessment of complication events during follow up.
From treatment initiation to 1 year follow up
Opioid Consumption
Tidsramme: Days 0-3 after treatment
Assessment of cumulative opioid consumption during hospitalization
Days 0-3 after treatment
Serum C-Reactive Protein Level
Tidsramme: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
D-Dimer Level
Tidsramme: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Hemoglobin Level
Tidsramme: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment

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 2026

Studieafslutning (Anslået)

30. december 2028

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • K20260153

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Kliniske forsøg med Fragility Fractures of the Pelvis (FFP)

Kliniske forsøg med Robot Assisted Minimally Invasive Fixation

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