Clinical trial NCT03430193: Fragility Fracture Integrated Rehabilitation Management (FIRM)
Official title: Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Keywords: rehabilitation
multi-disciplinary rehabilitation
clinical pathway
Fragility
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2018-02-12
Enrollment: 288
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.

Detailed description: The purpose of this prospective study

To develop a standardized fragility fracture integrated rehabilitation management (FIRM) based on the critical rehabilitation pathway for fragility fractures.

1. Standardization of initial evaluation for fall and re-fracture risks before rehabilitation
2. Standardization in initial screening for prevention for common complication after fracture and early diagnosis
3. Evidence based standardization in rehabilitation after fragility fracture
4. Development for safe return to normal daily life

Eligibility criteria: Inclusion Criteria:

1. Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture
2. Type of surgery : Bipolar hemiarthroplasty, THA, ORIF

Exclusion Criteria:

1. Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN
2. Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor
3. Combined multiple fracture (ex. Upper extremity)
4. Revision operation
5. Disagree to participation for clinical trial
6. Severe cognitive dysfunction (Obey command ≤1)

Primary outcomes:
measure: Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
Secondary outcomes:
measure: Change from baselines mobility status (KOVAL) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
measure: Change from baselines hand grip strength after rehabilitation
timeFrame: 0, 3 month, 6 month, 12 month
Other outcomes:
measure: Mortality
timeFrame: 0, 3 month, 6 month, 12 month
measure: Recovery to premorbid ambulatory status
timeFrame: 0, 3 month, 6 month, 12 month
Locations:
city: SeongNam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae-Young Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lee SY, Beom J, Kim BR, Lim SK, Lim JY; Fragility Fracture Rehabilitation Study Group. Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial. Medicine (Baltimore). 2018 May;97(20):e10763. doi: 10.1097/MD.0000000000010763.