Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip

Not Applicable

Completed

• Conditions: Bony Weight Bearing Disorder
• Interventions: Behavioral: Early-Weight bearing

• Registration Number: NCT06199739
• 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 14 proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. 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

• Study Start: 2020-01-01
• Primary Completion: 2022-04-30
• Study Completion: 2023-05-05
• Study First Submitted: 2023-07-07
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-28
• Last Update Submitted: 2023-12-28
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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: SINGLE_GROUP

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)
Complication	Functional and radiographic evaluations were performed at months 1, 3, 6, and 12 postoperatively	Loss of reduction, malunion or nonunion

Trial Locations

Locations (1)

Far-Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan