Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot Assisted Treatment Group | Experimental | Participants undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement for Tile B and C pelvic fractures. |
|
| Conventional Surgery Group | Active Comparator | Participants undergo conventional open surgical fixation for Tile B and C pelvic fractures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junbo Liang, Dr. | Contact | 0576-85190463 | liangjb@enzemed.com |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41013720 | Result | Lu Z, Xiuxiu H, Xing B. Retrospective analysis of the use of orthopedic reduction robots in treating low-energy osteoporotic unstable pelvic fractures in the elderly. J Orthop Surg Res. 2025 Sep 26;20(1):844. doi: 10.1186/s13018-025-06258-1. | |
| 19034594 | Result | Zwingmann J, Konrad G, Kotter E, Sudkamp NP, Oberst M. Computer-navigated iliosacral screw insertion reduces malposition rate and radiation exposure. Clin Orthop Relat Res. 2009 Jul;467(7):1833-8. doi: 10.1007/s11999-008-0632-6. Epub 2008 Nov 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment |
| 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. | At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment |
| Complication | From treatment initiation to 1 year follow up |
| Opioid Consumption | Assessment of cumulative opioid consumption during hospitalization | Postoperative Days 0-3 |
| Serum C-Reactive Protein Level | Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment. |
| D-Dimer Level | Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment. |
| Hemoglobin Level | Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment. |
| Operative Time | Duration of surgery measured in minutes. | Perioperative |
| Intraoperative Blood Loss | Estimated intraoperative blood loss measured in milliliters. | Perioperative |
| Length of Surgical Incision | Length of skin incision measured in centimeters. | Perioperative |
| 33590317 | Result | Hoffmann MF, Yilmaz E, Norvel DC, Schildhauer TA. Navigated iliac screw placement may reduce radiation and OR time in lumbopelvic fixation of unstable complex sacral fractures. Eur J Orthop Surg Traumatol. 2021 Oct;31(7):1427-1433. doi: 10.1007/s00590-021-02892-7. Epub 2021 Feb 16. |
| 33811488 | Result | Gericke L, Fritz A, Osterhoff G, Josten C, Pieroh P, Hoch A. Percutaneous operative treatment of fragility fractures of the pelvis may not increase the general rate of complications compared to non-operative treatment. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3729-3735. doi: 10.1007/s00068-021-01660-w. Epub 2021 Apr 3. |
| 41054280 | Result | Ran D, Wang C. Efficacy and safety of different fixation methods for unstable anterior pelvic ring fractures: a Bayesian network meta-analysis. Ann Med. 2025 Dec;57(1):2563000. doi: 10.1080/07853890.2025.2563000. Epub 2025 Oct 6. |
| 36119388 | Result | Lu S, Liu F, Xu W, Zhou X, Li L, Zhou D, Li Q, Dong J. Management of Open Tile C Pelvic Fractures and Their Outcomes: A Retrospective Study of 30 Cases. Ther Clin Risk Manag. 2022 Sep 10;18:929-937. doi: 10.2147/TCRM.S378740. eCollection 2022. |
| 37533441 | Result | de Ridder VA, Whiting PS, Balogh ZJ, Mir HR, Schultz BJ, Routt MC. Pelvic ring injuries: recent advances in diagnosis and treatment. OTA Int. 2023 Jun 16;6(3 Suppl):e261. doi: 10.1097/OI9.0000000000000261. eCollection 2023 Jun. |
| 38962370 | Result | Tienpratarn W, Nakpipat N, Yuksen C, Wongwaisayawan S, Phootothum Y, Jaiboon S. Clinical Associated Factors of Tile B/C Type of Pelvic Ring Fractures; a Retrospective Cross-sectional study. Arch Acad Emerg Med. 2024 May 12;12(1):e49. doi: 10.22037/aaem.v12i1.2243. eCollection 2024. |
| 41053562 | Result | Ding H, Wang W, Sun W, Liu L, Huang M, Han D, Lu Y, Zhou J, Pan J. Clinical characteristics and mortality risk factors in polytrauma patients with pelvic fractures: a retrospective study based on an integrated multidisciplinary treatment approach. Int J Emerg Med. 2025 Oct 6;18(1):192. doi: 10.1186/s12245-025-00990-5. |
| 40710040 | Result | Ohla J, Walus P, Wicinski M, Malkowski B, Turon B, Jablonski A, Gawryjolek M, Kellett K, Zabrzynski J. Pelvic Fractures in Adults and the Importance of Associated Injuries-A Current Multi-Disciplinary Approach. Clin Pract. 2025 Jul 11;15(7):130. doi: 10.3390/clinpract15070130. |
| 29250500 | Result | Hermans E, Biert J, Edwards MJR. Epidemiology of Pelvic Ring Fractures in a Level 1 Trauma Center in the Netherlands. Hip Pelvis. 2017 Dec;29(4):253-261. doi: 10.5371/hp.2017.29.4.253. Epub 2017 Dec 1. |
| D007869 |
| Leg Injuries |