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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 152
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Junbo Liang
Dr.
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University