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

ConditionFragility Fractures of the Pelvis (FFP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorJunbo Liang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robot Assisted Minimally Invasive Fixation

    Procedure/Surgery

    Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Robot Assisted Minimally Invasive Treatment GroupExperimental treatment 1 intervention
Group B: Conservative Treatment GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Scale (VAS) for Pain

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.

Time frame
At day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
2

Majeed Pelvic Function Score

Time frame
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment

Secondary outcomes

1

EuroQol 5-Dimension 3-Level Questionnaire

Time frame
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
2

Short Musculoskeletal Function Assessment (SMFA)

Time frame
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
3

Fracture Progression and Healing

Assessment of fracture healing, secondary displacement, and FFP classification progression using pelvic CT.

Time frame
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
4

complication

Assessment of complication events during follow up.

Time frame
From treatment initiation to 1 year follow up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Junbo Liang

Lead sponsor

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: