After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR)

Not Applicable

Recruiting

• Conditions: Bony Weight Bearing Disorder

• 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

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-08
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25
• Primary Completion: 2025-04-29
• Study Completion: 2025-04-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with AO/OTA type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table.

Exclusion Criteria

• 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

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