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

NCT07636616 | Not Yet Recruiting

• 1 other identifier: K20260153
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fragility Fractures of the Pelvis (FFP)

Keywords

Fragility Fracture; pelvis; Robot Assisted Surgery; Conservative Treatment

Outcome Measures

Primary Outcomes (2)

• 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 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

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

Secondary Outcomes (8)

• EuroQol 5-Dimension 3-Level Questionnaire

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

• Short Musculoskeletal Function Assessment (SMFA)

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

• Fracture Progression and Healing

  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

  Days 0-3 after treatment

Study Arms (2)

Robot Assisted Minimally Invasive Treatment Group

EXPERIMENTAL

Participants undergo robot assisted minimally invasive fixation for FFP1-2 fragility fractures of the pelvis.

Procedure: Robot Assisted Minimally Invasive Fixation

Conservative Treatment Group

ACTIVE COMPARATOR

Participants receive standardized conservative treatment including pain management, rehabilitation, anticoagulation prophylaxis, and osteoporosis treatment.

Procedure: Robot Assisted Minimally Invasive Fixation

Interventions

Robot Assisted Minimally Invasive Fixation PROCEDURE

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

Conservative Treatment Group; Robot Assisted Minimally Invasive Treatment Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Junbo Liang: lead

Related Publications (13)

• Zong Y, Li J, Li Z, Wang W. Minimally invasive surgery and conservative treatment achieve similar clinical outcomes in patients with type II fragility fractures of the pelvis. J Orthop Surg Res. 2025 Feb 27;20(1):210. doi: 10.1186/s13018-025-05581-x.

  PMID: 40016842 RESULT

• Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S. Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010 Mar 16;152(6):380-90. doi: 10.7326/0003-4819-152-6-201003160-00008.

  PMID: 20231569 RESULT

• Banierink H, Ten Duis K, de Vries R, Wendt K, Heineman E, Reininga I, IJpma F. Pelvic ring injury in the elderly: Fragile patients with substantial mortality rates and long-term physical impairment. PLoS One. 2019 May 28;14(5):e0216809. doi: 10.1371/journal.pone.0216809. eCollection 2019.

  PMID: 31136589 RESULT

• Yamamoto N, Someko H, Nakashima Y, Nakao S, Kaneko T, Tsuge T. Mortality following fragility fractures of the pelvis: Systematic review and meta-analysis. Injury. 2025 Oct;56(10):112618. doi: 10.1016/j.injury.2025.112618. Epub 2025 Jul 21.

  PMID: 40714375 RESULT

• Nakayama Y, Suzuki T, Kurozumi T, Watanabe Y. Progression to Rommens type IIIa fragility fracture of the pelvis managed by delayed open reduction and interdigitating screw fixation: A case report. Trauma Case Rep. 2023 Jan 13;43:100773. doi: 10.1016/j.tcr.2023.100773. eCollection 2023 Feb.

  PMID: 36691632 RESULT

• Rommens PM, Arand C, Hopf JC, Mehling I, Dietz SO, Wagner D. Progress of instability in fragility fractures of the pelvis: An observational study. Injury. 2019 Nov;50(11):1966-1973. doi: 10.1016/j.injury.2019.08.038. Epub 2019 Aug 27.

  PMID: 31492514 RESULT

• Jiang Y, Qi X, Cui H, Huang Y, Lv Y, Yang Y, Yao X, Yang D. The Inflammation-Energy Metabolism Axis: A Central Driver of Sarcopenia-Osteoporosis: A Narrative Review. Calcif Tissue Int. 2026 Jan 7;117(1):9. doi: 10.1007/s00223-025-01473-8.

  PMID: 41495343 RESULT

• Lin YH, Shih YT, Teng MMH. The Impact of the "Osteo" Component of Osteosarcopenia on Fragility Fractures in Post-Menopausal Women. Int J Mol Sci. 2021 May 17;22(10):5256. doi: 10.3390/ijms22105256.

  PMID: 34067582 RESULT

• Meermans G, van Egmond JC. Malnutrition in Older Hip Fracture Patients: Prevalence, Pathophysiology, Clinical Outcomes, and Treatment-A Systematic Review. J Clin Med. 2025 Aug 11;14(16):5662. doi: 10.3390/jcm14165662.

  PMID: 40869488 RESULT

• Rommens PM, Arand C, Hofmann A, Wagner D. When and How to Operate Fragility Fractures of the Pelvis? Indian J Orthop. 2019 Jan-Feb;53(1):128-137. doi: 10.4103/ortho.IJOrtho_631_17.

  PMID: 30905993 RESULT

• Ali KA, He L, Li W, Zhang W, Huang H. Sleep quality and psychological health in patients with pelvic and acetabulum fractures: a cross-sectional study. BMC Geriatr. 2024 Apr 4;24(1):314. doi: 10.1186/s12877-024-04929-y.

  PMID: 38575871 RESULT

• Hutchings L, Roffey DM, Lefaivre KA. Fragility Fractures of the Pelvis: Current Practices and Future Directions. Curr Osteoporos Rep. 2022 Dec;20(6):469-477. doi: 10.1007/s11914-022-00760-9. Epub 2022 Nov 7.

  PMID: 36342642 RESULT

• GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.

  PMID: 34723233 RESULT

Central Study Contacts

Junbo Liang

CONTACT

0576-85190463; liangjb@enzemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05