After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR)
- Conditions
- Bony Weight Bearing Disorder
- Interventions
- Behavioral: Early-Weight bearing
- Registration Number
- NCT06329271
- Lead Sponsor
- Far Eastern Memorial Hospital
- Brief Summary
Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.
Patients and methods:
For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Patients with AO/OTA type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table.
- Patients with pathological fractures, neurovascular insufficiency, ipsilateral lower extremity musculoskeletal injury, multiple fractures, or high risk of falling, including frequent falling accidents within 6 months, unsteady gait, ipsilateral neuropathy, limb weakness, and urinary incontinence were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early-Weight bearing Early-Weight bearing Early Weight bearing was defined as starting Weight bearing within 48 h postoperatively, and WBAT referred to the adjustment of fracture site weight-bearing by pain tolerance.
- Primary Outcome Measures
Name Time Method Harris Hip Functional score Functional and radiographic evaluations was performed at months 12 postoperatively The questionaire to patient. (HHS score 0-100,\<60 poor,\>80 good)
- Secondary Outcome Measures
Name Time Method Visual analog pain score Record at months 12 postoperatively Independent assessor (VAS:0-10, higher scores mean a worse outcome)
Complication Functional and radiographic evaluations were performed at week 1, months 1, 3, 6, and 12 postoperatively Loss of reduction, malunion, nonunion or medical complications
Trial Locations
- Locations (1)
Far-Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan