Hip Fractures Clinical Trial
— FIRMOfficial title:
Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients
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.
Status | Recruiting |
Enrollment | 288 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | SeongNam | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital | Korea Health Industry Development Institute |
Korea, Republic of,
Adunsky A, Lusky A, Arad M, Heruti RJ. A comparative study of rehabilitation outcomes of elderly hip fracture patients: the advantage of a comprehensive orthogeriatric approach. J Gerontol A Biol Sci Med Sci. 2003 Jun;58(6):542-7. — View Citation
Beaupre LA, Cinats JG, Senthilselvan A, Lier D, Jones CA, Scharfenberger A, Johnston DW, Saunders LD. Reduced morbidity for elderly patients with a hip fracture after implementation of a perioperative evidence-based clinical pathway. Qual Saf Health Care. 2006 Oct;15(5):375-9. — View Citation
Halbert J, Crotty M, Whitehead C, Cameron I, Kurrle S, Graham S, Handoll H, Finnegan T, Jones T, Foley A, Shanahan M; Hip Fracture Rehabilitation Trial Collaborative Group. Multi-disciplinary rehabilitation after hip fracture is associated with improved o — View Citation
Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 J — View Citation
Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. — View Citation
Lyons AR. Clinical outcomes and treatment of hip fractures. Am J Med. 1997 Aug 18;103(2A):51S-63S; discussion 63S-64S. Review. — View Citation
Magaziner J, Fredman L, Hawkes W, Hebel JR, Zimmerman S, Orwig DL, Wehren L. Changes in functional status attributable to hip fracture: a comparison of hip fracture patients to community-dwelling aged. Am J Epidemiol. 2003 Jun 1;157(11):1023-31. — View Citation
Sellier E, Labarere J, Sevestre MA, Belmin J, Thiel H, Couturier P, Bosson JL; Association pour la Promotion de l'Angiologie Hospitalière. Risk factors for deep vein thrombosis in older patients: a multicenter study with systematic compression ultrasonogr — View Citation
Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss E, Morrison RS. Early ambulation after hip fracture: effects on function and mortality. Arch Intern Med. 2006 Apr 10;166(7):766-71. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mortality | Mortality rate from number of dead patients among enrolled for the study | 0, 3 month, 6 month, 12 month | |
Other | Recovery to premorbid ambulatory status | Comparison premorbid ambulatory status with post-rehabilitation ambulatory status at each follow-up period | 0, 3 month, 6 month, 12 month | |
Primary | Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation | range, 0 to 5; decreasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines mobility status (KOVAL) after rehabilitation | range, 1 to 7; increasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation | range, 1 to 7; decreasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation | range, 0 to 56; decreasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation | range, 0 to 30; decreasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation | range, 0 to 30 ; increasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation | range, 0 to 1; decreasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation | range, 0 to 100; decreasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation | range, 0 to 3; increasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation | range, 0 to 5; increasingly worse | 0, 3 month, 6 month, 12 month | |
Secondary | Change from baselines hand grip strength after rehabilitation | measured by a a digital dynamometer (TKK 5401 Grip-D; Takei, Niigata, Japan) | 0, 3 month, 6 month, 12 month |
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