NCT07639619

Brief Summary

This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conventional surgery in elderly patients with FFP3-4 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 conventional surgical treatment. Primary and secondary outcomes include pain relief, early mobilization, functional recovery, perioperative complications, venous thromboembolism events, laboratory parameters, imaging outcomes, and healthcare resource utilization. The study aims to provide evidence for optimizing surgical treatment strategies in elderly patients with unstable pelvic fragility fractures.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

June 10, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 24, 2026

Last Update Submit

June 9, 2026

Conditions

Fragility Fractures of the Pelvis (FFP)Osteoporosis

Keywords

Fragility FractureRobot Assisted Surgerypelvis

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 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

Secondary Outcomes (10)

  • EuroQol 5-Dimension 3-Level Questionnaire

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

  • Fracture 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

    Time Frame: Postoperative Days 0-3

  • Short Musculoskeletal Function Assessment (SMFA)

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

  • +5 more secondary outcomes

Study Arms (2)

Robot Assisted Minimally Invasive Treatment Group

EXPERIMENTAL

Participants undergo robot assisted minimally invasive fixation for FFP3-4 fragility fractures of the pelvis using robotic navigation assisted percutaneous screw placement.

Procedure: Robot Assisted Minimally Invasive Fixation

Conventional Surgery Group

ACTIVE COMPARATOR

Participants undergo conventional open surgical fixation for FFP3-4 fragility fractures of the pelvis.

Procedure: Conventional Open Fixation

Interventions

Conventional Open FixationPROCEDURE

Conventional open reduction and internal fixation for FFP3-4 pelvic fragility fractures performed without robotic assistance.

Conventional Surgery Group
Robot Assisted Minimally Invasive FixationPROCEDURE

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

Robot Assisted Minimally Invasive Treatment Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years
  • Low energy trauma
  • Diagnosis of osteoporosis
  • Diagnosis of FFP3 or FFP4 fragility fractures of the pelvis
  • Injury duration less than 3 weeks
  • Ability to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 150 Ximen Road

Linhai, Zhejiang, 317000, China

Location

Related Publications (13)

  • 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: 34723233RESULT

  • 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: 36342642RESULT

  • 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: 38575871RESULT

  • 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: 30905993RESULT

  • Hitchener WR, Cenedella RJ. Absolute rates of sterol synthesis estimated from [3H]water for bovine lens epithelial cells in culture. J Lipid Res. 1985 Dec;26(12):1455-63.

    PMID: 4086948RESULT

  • Lau-Ting C. Asymptomatic hepatitis B antigen(s) carriers in Singapore: serological reassessment. Singapore Med J. 1988 Feb;29(1):11-3. No abstract available.

    PMID: 3406758RESULT

  • 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: 41495343RESULT

  • 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: 31492514RESULT

  • 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: 36691632RESULT

  • 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: 40714375RESULT

  • 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: 31136589RESULT

  • 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: 20231569RESULT

  • 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: 40016842RESULT

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Junbo Liang

CONTACT

0576-85190463lingjb@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
Director, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 10, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 30, 2028

Last Updated

June 10, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)