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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bony Weight Bearing Disorder
• Intervention / Treatment: Behavioral: Early-Weight bearing

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen Cheng Chen, Doctor; Phone Number: 886-919207805; Email: sstteevveepp@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 220
    • Recruiting
    • Far-Eastern Memorial Hospital
    • Contact: Yen Cheng Chen; Phone Number: 886919207805; Email: sstteevveepp@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Weight-bearing restriction; Weight bearing as toleration started after 48 h postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Functional score	The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)	Functional and radiographic evaluations was performed at months 1 postoperatively
Harris Hip Functional score	The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)	Functional and radiographic evaluations was performed at week 1 postoperatively
Harris Hip Functional score	The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)	Functional and radiographic evaluations was performed at months 3 postoperatively
Harris Hip Functional score	The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)	Functional and radiographic evaluations was performed at months 6 postoperatively
Harris Hip Functional score	The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)	Functional and radiographic evaluations was performed at months 12 postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog pain score	Independent assessor (VAS:0-10, higher scores mean a worse outcome)	Record at week 1 postoperatively
Visual analog pain score	Independent assessor (VAS:0-10, higher scores mean a worse outcome)	Record at months 1 postoperatively
Visual analog pain score	Independent assessor (VAS:0-10, higher scores mean a worse outcome)	Record at months 3 postoperatively
Visual analog pain score	Independent assessor (VAS:0-10, higher scores mean a worse outcome)	Record at months 6 postoperatively
Visual analog pain score	Independent assessor (VAS:0-10, higher scores mean a worse outcome)	Record at months 12 postoperatively
Complication	Loss of reduction, malunion, nonunion or medical complications	Functional and radiographic evaluations were performed at week 1, months 1, 3, 6, and 12 postoperatively

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Estimated): April 29, 2025
• Study Completion (Estimated): April 29, 2025

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: geriatrics; early weight-bearing; fracture reduction; proximal femur fracture
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Body Weight; Hip Fractures
• Other Study ID Numbers: 113022-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No