Clinical trial NCT06329271: After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR)
Official title: Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR) After Hip Fracture Nailing,
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bony Weight Bearing Disorder
Keywords: fracture reduction
proximal femur fracture
geriatrics
early weight-bearing
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at week 1 postoperatively
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at months 1 postoperatively
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at months 3 postoperatively
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at months 6 postoperatively
measure: Harris Hip Functional score
timeFrame: Functional and radiographic evaluations was performed at months 12 postoperatively
Secondary outcomes:
measure: Visual analog pain score
timeFrame: Record at week 1 postoperatively
measure: Visual analog pain score
timeFrame: Record at months 1 postoperatively
measure: Visual analog pain score
timeFrame: Record at months 3 postoperatively
measure: Visual analog pain score
timeFrame: Record at months 6 postoperatively
measure: Visual analog pain score
timeFrame: Record at months 12 postoperatively
measure: Complication
timeFrame: Functional and radiographic evaluations were performed at week 1, months 1, 3, 6, and 12 postoperatively
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far-Eastern Memorial Hospital
Study officials:
References: