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Robot Assisted Treatment Versus Conventional Surgery for Tile B and C Pelvic Fractures

ConditionPelvic Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJunbo Liang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Diagnosis of Tile B or Tile C pelvic fracture

Injury duration less than 3 weeks

Ability to provide written informed consent

Disqualifiers

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

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 unstable pelvic fractures.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Robot Assisted Treatment GroupExperimental treatment 1 intervention
Group B: Conventional Surgery 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 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
2

Majeed Pelvic Function Score

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.

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

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.

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)

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.

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

Imaging Outcomes and Fracture Healing

Assessment of fracture healing, secondary displacement, bone mineral density changes, and muscle mass changes using pelvic CT and imaging examinations.

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

Complication

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: