- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06199739
Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip
Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip Fracture
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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New Taipei City, Taiwan, 220
- Far-Eastern Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harris Hip Functional score
Time Frame: Functional and radiographic evaluations was performed at months 1 postoperatively
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The questionaire to patient.
(HHS score 0-100,<60 poor,>80 good)
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Functional and radiographic evaluations was performed at months 1 postoperatively
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Harris Hip Functional score
Time Frame: Functional and radiographic evaluations was performed at months 3 postoperatively
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The questionaire to patient(HHS score 0-100,<60 poor,>80 good)
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Functional and radiographic evaluations was performed at months 3 postoperatively
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Harris Hip Functional score
Time Frame: Functional and radiographic evaluations was performed at months 6 postoperatively
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The questionaire to patient(HHS score 0-100,<60 poor,>80 good)
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Functional and radiographic evaluations was performed at months 6 postoperatively
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Harris Hip Functional score
Time Frame: Functional and radiographic evaluations was performed at months 12 postoperatively
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The questionaire to patient(HHS score 0-100,<60 poor,>80 good)
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Functional and radiographic evaluations was performed at months 12 postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analog pain score
Time Frame: Record at months 1 postoperatively
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Independent assessor (VAS:0-10)
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Record at months 1 postoperatively
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visual analog pain score
Time Frame: Record at months 3 postoperatively
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Independent assessor(VAS:0-10)
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Record at months 3 postoperatively
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visual analog pain score
Time Frame: Record at months 6 postoperatively
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Independent assessor(VAS:0-10)
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Record at months 6 postoperatively
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visual analog pain score
Time Frame: Record at months 12 postoperatively
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Independent assessor(VAS:0-10)
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Record at months 12 postoperatively
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Complication
Time Frame: Functional and radiographic evaluations were performed at months 1, 3, 6, and 12 postoperatively
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Loss of reduction, malunion or nonunion
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Functional and radiographic evaluations were performed at months 1, 3, 6, and 12 postoperatively
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 109046-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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