ICTRP Search Portal

Main

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:	DRKS00006096
Date of registration:	11/07/2014
Prospective Registration:	Yes
Primary sponsor:	Elbe Klinikum Stade
Public title:	A new dissection and strong suture repair of the pronator quadratus muscle after volar plate fixation at the distal radius: a prospective randomized study
Scientific title:	A new dissection and strong suture repair of the pronator quadratus muscle after volar plate fixation at the distal radius: a prospective randomized study
Date of first enrolment:	21/07/2014
Target sample size:	34
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00006096
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Bernd Hohendorff
Address:	Bremervörder Straße 111 21684 Stade Germany
Telephone:	04141-972897
Email:	bernd.hohendorff@elbekliniken.de
Affiliation:	Elbe Klinikum Stade

Name:	Bernd Hohendorff
Address:	Bremervörder Straße 111 21684 Stade Germany
Telephone:	04141-972897
Email:	bernd.hohendorff@elbekliniken.de
Affiliation:	Elbe Klinikum Stade

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: All patients between 18 and 90 years with simple extraarticular and intraarticular distal radius fractures
Exclusion criteria: Exclusion criteria: Childs under 18 years of age; complex distal radius fractures; additional required fixation materials beside the volar plate; additional approaches beside the volar approach; additional injuries; already operated at the respective distal radius

Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

S52.51

Intervention(s)

Group 1: Repair of the pronator quadratus muscle with a part of the brachioradialis tendon
Group 2: Repair of the pronator quadratus muscle after incision through the muscle

Primary Outcome(s)

End point of the study: Clinical and ultrasound evaluation of 17 patients in the trial and controll group respectively at one year follow-up

Primary outcome measure: Integrety of the pronator quadratus muscle

Measurements: range of motion of the wrist; grip force; pronation force; ultrasound of the pronator quadratus muscle; Disabilities of the Arm, Shoulder and Hand (DASH) and Mayo Wrist Score

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Elbe Klinikum Stade

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 16/06/2014
Contact:

gs-ek@uni-koeln.de

Ethikkommission der Medizinischen Fakultät der Universität zu Köln

+49-221-478 82900

gs-ek@uni-koeln.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00006096#studyResults

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.