No registrations found.
ID
Source
Brief title
Health condition
Proximal femoral fracture
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life, measured with the EuroQoL-5D
Secondary outcome
Quality of life measured with the QUALIDEM; pain and pain medication; satisfaction of patient (or proxy) and caregivers with the management approach; time to death; direct medical costs.
Background summary
BACKGROUND
A proximal femoral fracture is strongly associated with mortality. Mortality is highest among elderly with both physical and cognitive comorbidities. There are no strict guidelines on whether or not to operate these patients. NICE advises to discuss if patients are open to hospital admission and possible surgery, and Dutch guidelines advocate operative treatment in patients with a life expectancy beyond six weeks. Common practice is to decide on treatment based on shared decision, yet nonoperative management is not commonly used. Practice variation occurs, and it remains unknown if nonoperative treatment would result in at least the same quality of life of femoral fracture patients who are institutionalized and have a limited life expectancy. Treatment decision will be reached following a structured shared decision process, in which pros and cons of both operative and nonoperative management are discussed with patients, their relatives, and all relevant care providers involved.
AIM
The primary aim is to determine the effect of nonoperative management versus operative management on the quality of life (EQ-5D) until six months in frail institutionalized elderly with a limited life expectancy who fracture their proximal femur. Secondary aims are to determine the effect of nonoperative management versus operative management on the quality of life (QUALIDEM), level of pain (PACSLAC-D) and use of analgesic medication, rate of complications, time to death, the satisfaction of the patient’s relatives and caregiver with the management strategy and health care consumption (with associated costs) in these patients. The ultimate aim is to determine the cost-efficacy of nonoperative management versus operative management in these patients.
STUDY DESIGN
Multicenter, observational cohort study.
POPULATION
Frail institutionalized elderly (70 years or older who have a body mass index <18.5, a Functional Ambulation Category of 2 or lower pre-trauma, or an ASA 4-5), who sustained a proximal femoral fracture.
INTERVENTION
Following a structured shared decision process, patients and treating physicians will decide on the best treatment for each individual patient. This will be:
1) Nonoperative management
2) Operative management
ENDPOINTS
Primary outcome measure: quality of life (EQ-5D).
Secondary outcome measures: quality of life (QUALIDEM); pain and pain medication; satisfaction of patient (or proxy) and caregivers with the management approach; time to death; and direct medical costs.
Data will be collected at 7, 14, and 30 days, and 3 and 6 months after trauma.
RECRUITING COUNTRIES
The Netherlands
Study objective
We expect that quality of life after nonoperative treatment is at least as good as after operative treatment.
Study design
Seven, 14, and 30 days, and 3 and 6 months after trauma.
Intervention
Patients in the intervention group will be treated nonoperatively. The control group will receive operative management.
P. Joosse
P.O. Box 501
Alkmaar 1800 AM
The Netherlands
072-5482422
p.joosse@nwz.nl
P. Joosse
P.O. Box 501
Alkmaar 1800 AM
The Netherlands
072-5482422
p.joosse@nwz.nl
Inclusion criteria
1) Frail institutionalized elderly person (i.e., 70 years or older, living in a nursing home pretrauma, who either are malnutritioned (cachexia of BMI<18.5 kg/m2), or had mobility issues (FAC 2 or less), or have an ASA class of 4 or 5)
2) Acute proximal femoral fracture, confirmed on X-ray or CT-scan
3) Informed consent by patient, or by proxy in patients with mental impairment
Exclusion criteria
1) Bilateral proximal femoral fractures
2) Periprosthetic fracture
3) Fracture diagnosed > 7 days after trauma
4) Patients with a known metastatic disease and a confirmed pathological fracture of the proximal femur
5) Insufficient comprehension of Dutch language to understand rehabilitation programs and other treatment information (this applies to the person signing consent, being either the patient or proxy)
6) Participation in another surgical intervention or drug study that might influence any of the outcome parameters
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7040 |
NTR-old | NTR7245 |
Other | : 018.208 (METC VUmc) |