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Completed

NCT Number: NCT06199739

Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip

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.

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Key information

Conditions

Bony Weight Bearing Disorder Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Proximal Femoral Fractures Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Far-Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early-Weight bearing

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.

Primary outcomes

  1. Harris Hip Functional score

    Time frame: Functional and radiographic evaluations was performed at months 1 postoperatively

    The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)

  2. Harris Hip Functional score

    Time frame: Functional and radiographic evaluations was performed at months 3 postoperatively

    The questionaire to patient(HHS score 0-100,<60 poor,>80 good)

  3. Harris Hip Functional score

    Time frame: Functional and radiographic evaluations was performed at months 6 postoperatively

    The questionaire to patient(HHS score 0-100,<60 poor,>80 good)

  4. Harris Hip Functional score

    Time frame: Functional and radiographic evaluations was performed at months 12 postoperatively

    The questionaire to patient(HHS score 0-100,<60 poor,>80 good)

Secondary outcomes

  1. visual analog pain score

    Time frame: Record at months 1 postoperatively

    Independent assessor (VAS:0-10)

  2. visual analog pain score

    Time frame: Record at months 3 postoperatively

    Independent assessor(VAS:0-10)

  3. visual analog pain score

    Time frame: Record at months 6 postoperatively

    Independent assessor(VAS:0-10)

  4. visual analog pain score

    Time frame: Record at months 12 postoperatively

    Independent assessor(VAS:0-10)

  5. Complication

    Time frame: Functional and radiographic evaluations were performed at months 1, 3, 6, and 12 postoperatively

    Loss of reduction, malunion or nonunion

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip Fracture

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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