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Fragility Fractures of the Pelvis (FFP)NCT07639619

Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery for FFP3-4 Fragility Fractures of the Pelvis in Elderly Patients

A study testing Robot Assisted Minimally Invasive Fixation and Conventional Open Fixation in people with Fragility Fractures of the Pelvis (FFP) and Osteoporosis, run by Junbo Liang at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Robot Assisted Minimally Invasive Fixation and Conventional Open Fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
1 Jun 2026to 30 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • No. 150 Ximen Road

    Linhai, Zhejiang, 317000

    Junbo Liang, 0576-85190463, liangjb@enzemed.com

Other trials in China

About this study

Official title: Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery in Elderly Patients With FFP3-4 Fragility Fractures of the Pelvis

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.

Read the detailed description

This study is a prospective, single center, stratified randomized controlled trial designed 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.

A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conventional surgery group. Randomization will be stratified according to FFP classification (FFP3 or FFP4) using a computer generated randomization sequence.

Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP3 or FFP4 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, venous thromboembolism events, laboratory parameters, complications, opioid consumption, and healthcare resource utilization between treatment strategies.

Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic 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, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, 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 elderly patients with unstable pelvic fragility fractures.

Being tested
Robot Assisted Minimally Invasive Fixation, Conventional Open Fixation
Keywords
Fragility Fracture, Robot Assisted Surgery, pelvis
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot Assisted Minimally Invasive FixationProcedure or surgery

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

  • Conventional Open FixationProcedure or surgery

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

Study groups in NCT07639619
Study groupRoleWhat they receive
Robot Assisted Minimally Invasive Treatment GroupExperimentalParticipants undergo robot assisted minimally invasive fixation for FFP3-4 fragility fractures of the pelvis using robotic navigation assisted percutaneous screw placement.
Receives: Procedure: Robot Assisted Minimally Invasive Fixation
Conventional Surgery GroupActive comparatorParticipants undergo conventional open surgical fixation for FFP3-4 fragility fractures of the pelvis.
Receives: Procedure: Conventional Open Fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Secondary outcomes (10)
  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.

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

  2. Fracture Healing

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

  3. Complication

    Measured: From treatment initiation to 1 year follow up

  4. Opioid Consumption

    Assessment of cumulative opioid consumption during hospitalization

    Measured: Time Frame: Postoperative Days 0-3

  5. 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.

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

  6. Serum C-Reactive Protein Level

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

  7. Hemoglobin Level

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

  8. Operative time

    Duration of surgery measured in minutes.

    Measured: perioperative

  9. Intraoperative Blood Loss

    Estimated intraoperative blood loss measured in milliliters.

    Measured: perioperative

  10. Length of Surgical Incision

    Length of skin incision measured in centimeters.

    Measured: perioperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07639619
Sponsor's protocol ID
K20260303
Status last verified
May 2026
First submitted
24 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34723233
  • 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.

    PubMed 36342642
  • 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.

    PubMed 38575871
  • 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.

    PubMed 30905993
  • 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.

    PubMed 4086948
  • 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.

    PubMed 3406758
  • 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.

    PubMed 41495343
  • 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.

    PubMed 31492514
  • 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.

    PubMed 36691632
  • 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.

    PubMed 40714375
  • 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.

    PubMed 31136589
  • 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.

    PubMed 20231569
  • 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.

    PubMed 40016842

Questions about this trial

What is this clinical trial studying?

A study testing Robot Assisted Minimally Invasive Fixation and Conventional Open Fixation in people with Fragility Fractures of the Pelvis (FFP) and Osteoporosis, run by Junbo Liang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junbo Liang (0576-85190463, lingjb@enzemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07639619, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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