Comparison of Two Volar Plating Systems for Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:

Comparison of Two Volar Plating Systems for Distal Radius Fractures - A Prospective Randomized Single-blinded Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474445
• Other study ID #: 2339/2016
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We plan to compare 2 types of plating systems for volar plating of distal radius fractures (Aptus 2.5® Medartis AG, Basel, Switzerland vs. INTEOS 2.5® - Hofer Medical GmbH and Co KG, Austria) in a prospective single-blinded controlled clinical trial.

Description:

This study represents a prospective randomized clinical trial comparing two different systems of volar plate osteosynthesis in patients with distal radius fractures. Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Envelopes will be prepared containing equal number of cards representing either the conventional or the novel plating syste. On the morning of the surgery a randomly picked envelope decides allocation one of the study groups. Patients will be blinded to treatment until completion of the study. Patients allocated to the control group receive Aptus 2.5® volar plate for distal radius fractures (Medartis AG, Basel, Switzerland), while patients in the study group will receive the plating system INTEOS 2.5® (Hofer GmbH and Co KG, Austria). In the control group, the pronator quadratus muscle will be cut prior mounting of the plate, while in the treatment group the plate will be inserted underneath the pronator quadratus leaving the muscle intact.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 28, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• " Distal radius fracture, Type A2, A3, B1, B2, B3, C1, C2 (according to AO Müller classification3) " Patient age between 18 and 75 years " Closed fracture or I° open fractures (according to Gustilo-Anderson classification6) " Agreement of patient to participate and written informed consent

Exclusion Criteria:

• " Polytraumatized patients " Severe systemic disorder (ASA 3) " New and/or preexisting fracture/Injury of contralateral forearm " II° and III° open fractures (according to Gustilo-Anderson classification6) " Associated injuries of the ipsilateral wrist (e.g. scapholunate dissociation, concomitant fractures) " Non-compliance to postoperative protocol (e.g. physiotherapy) " Delayed definitive surgical treatment of more than 14 days after injury " Change from temporary procedure (e.g. Fixateur externe) " Complex regional pain syndrome (CRPS, M.Sudeck) " Loss to follow-up

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Volar Plate Osteosynthesis Aptus 2.5
Volar plating of distal radius fracture. Device: Aptus 2.5
• Volar Plate Osteosynthesis Inteos 2.5
Volar plating of distal radius fracture. Device: Inteos 2.5

Locations

Country	Name	City	State
Austria	Medical Universtiy of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient rated wrist evaluation	Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score	12 months
Secondary	Mayo wrist score	Function-based evaluation of the wrist, range 0-100, 90-100=very good, 80-89=good, 65-79=satisfying, <65=poor	8 weeks, 3 months, 6 months, 12 months
Secondary	Radiological Outcome	x-ray based outcome of plate osteosynthesis (including ap and volar inclination angles, joint congruency, ulna length). Measurements will be performed on digitalised radiographs with IMPAX viewer (Agfa Ges.m.bH)	2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months
Secondary	strength measurement	dynamometer-based strength evaluation	4 weeks, 8 weeks, 3 months, 6 months, 12 months
Secondary	Volumetric evaluation	With a standardised device using water displacement wirst swelling will be assessed.	4 weeks, 8 weeks, 3 months, 6 months, 12 months
Secondary	Disabilities of the Arm, Shoulder and Hand, Outcome Score - DASH	patient-based standardised questionnaire, 30 items, range 0-100, 0=best outcome, 100=worst outcome	4 weeks, 8 weeks, 3 months, 6 months, 12 months
Secondary	Patient rated wrist evaluation	Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score	4 weeks, 8 weeks, 3 months, 6 months