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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.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00009270
Date of registration:	26/08/2015
Prospective Registration:	No
Primary sponsor:	Universitätsklinikum FreiburgKlinik für Orthopädie und Unfallchirurgie
Public title:	Decision Making in Patients with acute ACL ruptures - A world-wide database using Apple ResearchKit
Scientific title:	Decision Making in Patients with acute ACL ruptures - A world-wide database using Apple ResearchKit - MRA-ACL
Date of first enrolment:	22/07/2015
Target sample size:	10000
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00009270
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
Phase:

Countries of recruitment
Argentina	Australia	Austria	Chile	China	Germany	Mexico	Peru
Spain	Switzerland	United Kingdom	United States	Uruguay	Venezuela

Contacts

Name:	Philipp Niemeyer
Address:	Hugstetter Str. 55 79106 Freiburg Germany
Telephone:	+ 49 761 270 24010
Email:	philipp.niemeyer@uniklinik-freiburg.de
Affiliation:	Universitätsklinikum FreiburgKlinik für Orthopädie und Unfallchirurgie

Name:	Martin Zens
Address:	Hugstetter Str. 55 79106 Freiburg Germany
Telephone:	+49 761 203 67491
Email:	martin.zens@imtek.uni-freiburg.de
Affiliation:	Universitätsklinikum FreiburgKlinik für Orthopädie und Unfallchirurgie

Key inclusion & exclusion criteria

Inclusion criteria: acute rupture of the anterior cruciate ligament (ACL)
Exclusion criteria: Children and minor under 18, previous injuries of the ACL, previous surgery of the knee joint, unable to give consent

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

S83.53

Intervention(s)

Group 1: Patients > 18 years old with an acute rupture of the anterior cruciate ligament (ACL) /
Based on Apple ResearchKit an app for mobile devices is created to collect data about the recovery of participants from time to time. The data are collected thorugh surveys on a mobile device.

Primary Outcome(s)

The outcome of patients during therapy should be evaluated with an individually developed survey (9 scoring questions) 12 months after commencing treatment.

Secondary Outcome(s)

The outcome of patients during therapy should be evaluated with an individually developed survey (9 scoring questions) 36 months after commencing treatment.

Secondary ID(s)

Source(s) of Monetary Support

Universitätsklinikum FreiburgKlinik für Orthopädie und Unfallchirurgie

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 14/07/2015
Contact:

ekfr.mpg@uniklinik-freiburg.de

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

+49-761-27072600

ekfr.mpg@uniklinik-freiburg.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00009270#studyResults

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