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

NCT ID: NCT06329271

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2025-04-29

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.

Conditions

Bony Weight Bearing Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early-Weight bearing

Intervention Type: BEHAVIORAL

The patients began early weight bearing under attending physician and physiotherapist surveillance within 48 hours after surgery. Patients were instructed to stand up near the bed, and muscle power, gait stability, and pain tolerance were recorded. The physiotherapist instructed the patients to perform early mobilization and weight bearing as tolerable by self-adjustment of body weight distribution over the bilateral lower extremities, and walking assistance was used to prevent repeat falling accidents.

Weight-bearing restriction

Weight bearing as toleration started after 48 h postoperatively.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early-Weight bearing

The patients began early weight bearing under attending physician and physiotherapist surveillance within 48 hours after surgery. Patients were instructed to stand up near the bed, and muscle power, gait stability, and pain tolerance were recorded. The physiotherapist instructed the patients to perform early mobilization and weight bearing as tolerable by self-adjustment of body weight distribution over the bilateral lower extremities, and walking assistance was used to prevent repeat falling accidents.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Far-Eastern Memorial Hospital

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yen Cheng Chen, Doctor

Role: CONTACT

sstteevveepp@gmail.com

886-919207805

Facility Contacts

Yen Cheng Chen

Role: primary

sstteevveepp@gmail.com

886919207805

Other Identifiers

113022-E

Identifier Type: -

Identifier Source: org_study_id