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NCT Number: NCT07624942

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

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.

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Key information

Conditions

Pelvic Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures.

A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted treatment group or the conventional surgery group. Randomization will be stratified according to Tile fracture classification (Tile B or Tile C) using a computer generated randomization sequence.

Eligible participants include adult patients diagnosed with Tile B or Tile C pelvic fractures within 3 weeks after injury. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, complications, opioid consumption, and healthcare resource utilization between treatment strategies.

Patients in the robot assisted treatment group will undergo robot assisted minimally invasive 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, laboratory parameters, venous thromboembolism events, 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 Tile B and C pelvic fractures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of Tile B or Tile C pelvic fracture
  • 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

Treatment and study plan

Robot Assisted Minimally Invasive Fixation

Procedure

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

Primary outcomes

  1. Visual Analog Scale (VAS) for Pain

    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

    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.

  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

    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.

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

    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.

  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

    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.

  3. Imaging Outcomes and Fracture Healing

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

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

  4. Complication

    Time frame: From treatment initiation to 1 year follow up

  5. Opioid Consumption

    Time frame: Postoperative Days 0-3

    Assessment of cumulative opioid consumption during hospitalization

  6. Serum C-Reactive Protein Level

    Time frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.

  7. D-Dimer Level

    Time frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.

  8. Hemoglobin Level

    Time frame: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.

  9. Operative Time

    Time frame: Perioperative

    Duration of surgery measured in minutes.

  10. Intraoperative Blood Loss

    Time frame: Perioperative

    Estimated intraoperative blood loss measured in milliliters.

  11. Length of Surgical Incision

    Time frame: Perioperative

    Length of skin incision measured in centimeters.

Study contacts

Contact information is provided by the study sponsor or research team.

Junbo Liang, Dr.

CONTACT

[email protected]

0576-85190463

Sponsors and collaborators

Lead sponsor

Junbo Liang

Other

Registry information

Official study title

Comparing the Efficacy and Safety of Robot Assisted Treatment Versus Conventional Surgery in Patients With Tile B and C Pelvic Fractures

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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