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

June 3, 2026 updated by: Junbo Liang

Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment in Elderly Patients With FFP1-2 Fragility Fractures of the Pelvis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis.

A total of 152 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conservative treatment group. Randomization will be stratified according to FFP classification (FFP1 or FFP2) using a computer generated randomization sequence.

Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP1 or FFP2 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare pain control, early weight bearing, functional recovery, fracture progression, venous thromboembolism events, and healthcare resource utilization between treatment strategies.

Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic fixation, while patients in the conservative treatment group will receive standardized nonoperative management including pain control, anticoagulation prophylaxis, rehabilitation, and osteoporosis treatment.

Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture progression and healing, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, opioid consumption, 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 treatment strategy for elderly patients with FFP1-2 pelvic fragility fractures.

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot Assisted Minimally Invasive Treatment Group
Participants undergo robot assisted minimally invasive fixation for FFP1-2 fragility fractures of the pelvis.
Procedure: Robot Assisted Minimally Invasive Fixation
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures.
Active Comparator: Conservative Treatment Group
Participants receive standardized conservative treatment including pain management, rehabilitation, anticoagulation prophylaxis, and osteoporosis treatment.
Procedure: Robot Assisted Minimally Invasive Fixation
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) for Pain
Time Frame: At 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.
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
Time Frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Fracture Progression and 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, and FFP classification progression using pelvic CT.
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
complication
Time Frame: From treatment initiation to 1 year follow up
Assessment of complication events during follow up.
From treatment initiation to 1 year follow up
Opioid Consumption
Time Frame: Days 0-3 after treatment
Assessment of cumulative opioid consumption during hospitalization
Days 0-3 after treatment
Serum C-Reactive Protein Level
Time Frame: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
D-Dimer Level
Time Frame: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Hemoglobin Level
Time Frame: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Junbo Liang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

May 24, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K20260153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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