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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00011934 |
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Date of registration:
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10/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Activity tracking in elderly patients after operative treatment of proximal femur fractures
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Scientific title:
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Activity tracking in elderly patients after operative treatment of proximal femur fractures - ACTProFem |
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Date of first enrolment:
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11/03/2017 |
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Target sample size:
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126 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00011934 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis
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Phase:
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Countries of recruitment
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Denmark
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Germany
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Contacts
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Name:
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Hagen
Schmal |
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Address:
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Sdr. Boulevard 29
5000
Odense C
Denmark |
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Telephone:
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ß45 29428705 |
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Email:
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hagen.schmal@rsyd.dk |
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Affiliation:
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University Hospital Odense, Department of Orthopaedics and Traumatology |
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Name:
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Hagen
Schmal |
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Address:
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Sdr. Boulevard 29
5000
Odense C
Denmark |
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Telephone:
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ß45 29428705 |
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Email:
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hagen.schmal@rsyd.dk |
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Affiliation:
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University Hospital Odense, Department of Orthopaedics and Traumatology |
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Key inclusion & exclusion criteria
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Inclusion criteria: •Existence of a proximal femoral fracture including the locations AO 31 and 32 (intervention group, n=48 per center)
•Or existence of a fracture of the upper extremity including the locations AO 11,12,13, 21, 22 and 23 (control group, n=15)
•Age = 65 years
•Being able to read and understand German or Danish
•Informed consent
Exclusion criteria: •Open fractures
•Polytrauma
•Colonization with multiresistent bacteria
•Preoperatively bedridden patients
•Infection of the wound
•Operative revisions because of other reasons
Age minimum:
65 Years
Age maximum:
120 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pertrochanteric fracture
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Subtrochanteric fracture
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S72.0
S72.1
S72.2
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S72.2
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Fracture of neck of femur
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S72.0
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S72.1
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Intervention(s)
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Group 1: Activity measurement in patients suffering from a proximal femoral fracture including the locations AO 31 and 32
Group 2: Activity measurement in patients suffering from a forearm fracture including the locations AO 11, 12, 13, 21, 22 and 23 (upper extremity)
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Primary Outcome(s)
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Percentage of the active time measured using an activity tracker and a threshold, which was adapted to this special patient population. The activity is registered at two time points: day 2+/-1 and 8+/-3 after surgery.
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Secondary Outcome(s)
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Active minutes per day measured at two time points: day 2+/-1 and 8+/-3 after surgery, the questionnaire EQ-5D 3L (quality of life), the handicap index Barthel 20 based on questioning the patient and the nursing staff, complications are registered
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Secondary ID(s)
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U1111-1194-6780
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OP 238
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Source(s) of Monetary Support
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University Hospital Odense
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Rigshospital Copenhagen
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Ethics review
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Status: Approved
Approval date: 15/12/2015
Contact:
ekfr.mpg@uniklinik-freiburg.de
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
+49-761-27072600
ekfr.mpg@uniklinik-freiburg.de
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