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

F

Far Eastern Memorial Hospital

Status

Enrolling

Conditions

Bony Weight Bearing Disorder

Treatments

Behavioral: Early-Weight bearing

Study type

Interventional

Funder types

Other

Identifiers

NCT06329271
113022-E

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Early-Weight bearing
Experimental group
Description:
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.
Treatment:
Behavioral: Early-Weight bearing
Weight-bearing restriction
No Intervention group
Description:
Weight bearing as toleration started after 48 h postoperatively.

Trial contacts and locations

1

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Central trial contact

Yen Cheng Chen, Doctor

Data sourced from clinicaltrials.gov

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