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Activity tracking in elderly patients after operative treatment of proximal femur fractures

Organizational Data

DRKS-ID:
DRKS00011934
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2017-04-10
Last update in DRKS:
2017-08-18
Registration type:
Retrospective

Acronym/abbreviation of the study

ACTProFem

URL of the study

https://open.rsyd.dk/OpenProjects/da/openProject.jsp?openNo=238

Brief summary in lay language

Elderly patients commonly suffer from hip fractures. These injuries are frequently associated with patients' dead, but objective tools to observe the recovery process are lacking. Physical activity is recognized as the key for the recovery process. Therefore, we think that activity trackers can reliably monitor the early phase after an operation and be used as this missing instrument. Standardized step counts are recorded using wearables or activity trackers and analyzed together with factors characterizing patient’s general and current health, epidemiology, and blood values. These data are the basis for the development of a 'traffic light' system. This can signal personal treatment demands and progress of recovery bz green/yellow/red colors. Data obtained by the used trackers enable a subgroup analysis of patients with femoral neck fractures, comparing two different standardized treatment methods in two different centers (Denmark and Germany). The regular use of wearables can be part of an individualized treatment in future and add a safety feature.

Brief summary in scientific language

Elderly patients commonly suffer from proximal femoral fractures. These injuries are associated with a high mortality, however, objective tools to observe the recovery process are lacking. Physical activity is recognized as the key for the recuperation process. Therefore, we hypothesize that activity trackers can reliably monitor the early postoperative follow-up and be utilized as this missing instrument. Standardized step counts are recorded using wearables and analyzed in association with factors characterizing patient’s general and current health, epidemiology, and biochemical parameters. Minute-by-minute data are the basis for the development of a management-suited reporting system. This can facilitate signaling of personal treatment demands and progress of recovery. Data obtained by the used trackers enable a subgroup analysis of patients with femoral neck fractures, comparing two different standardized treatment methods in two different centers. The regular use of wearables can be part of an individualized treatment coordination in future and add a safety feature.

Health condition or problem studied

ICD10:
S72.0 - Fracture of neck of femur
ICD10:
S72.1 - Pertrochanteric fracture
ICD10:
S72.2 - Subtrochanteric fracture
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Activity measurement in patients suffering from a proximal femoral fracture including the locations AO 31 and 32
Arm 2:
Activity measurement in patients suffering from a forearm fracture including the locations AO 11, 12, 13, 21, 22 and 23 (upper extremity)

Endpoints

Primary outcome:
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.
Secondary outcome:
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

Study Design

Purpose:
Prognosis
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Denmark
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Department of Orthopaedics and Traumatology Odense
  • University medical center Department of Orthopaedics and Traumatology Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
2017-04-01
Actual study start date:
2017-03-11
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
126
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
65 Years
Maximum Age:
120 Years
Additional 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

Addresses

Primary Sponsor

University Hospital Odense, Department of Orthopaedics and Traumatology
Prof. Hagen Schmal
Sdr. Boulevard 29
5000 Odense C
Denmark
Telephone:
ß45 29428705
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ouh.dk/wm373898
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

University Hospital Odense, Department of Orthopaedics and Traumatology
Prof. Hagen Schmal
Sdr. Boulevard 29
5000 Odense C
Denmark
Telephone:
ß45 29428705
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ouh.dk/wm373898

Contact for Public Queries

University Hospital Odense, Department of Orthopaedics and Traumatology
Prof. Hagen Schmal
Sdr. Boulevard 29
5000 Odense C
Denmark
Telephone:
ß45 29428705
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ouh.dk/wm373898

Principal Investigator

University Hospital Odense, Department of Orthopaedics and Traumatology
Prof. Hagen Schmal
Sdr. Boulevard 29
5000 Odense C
Denmark
Telephone:
ß45 29428705
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ouh.dk/wm373898

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

University Hospital Odense
Sdr. Boulevard 29
5000 Odense
Denmark
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Private sponsorship (foundations, study societies, etc.)

Rigshospital Copenhagen
Juliane Maries Vej 20
2100 Copenhagen
Denmark
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2015-10-15
Ethics committee number:
287/15
Vote of the Ethics Committee:
Approved
Date of the vote:
2015-12-15

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
OP 238 - Odense patient data explorative network (OPEN)
UTN (Universal Trial Number):
U1111-1194-6780
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
Protocol Version 2-0
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry