Fragility Fracture Integrated Rehabilitation Management (FIRM)

Hip Fractures Clinical Trial

— FIRM  

Official title:

Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03430193
• Other study ID #: HC15C1189
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2021
• Source: Seoul National University Bundang Hospital
• Contact: Seung-Kyu Lim, MD
• Phone: +821096045700
• Email: flyingmango77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Other:
• FIRM
FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.
• Conventional rehabilitation
Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	SeongNam	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

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

Outcome

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