NCT03474445

Comparison of Two Volar Plating Systems for Distal Radius Fractures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
PROCEDURE	Volar Plate Osteosynthesis Aptus 2.5	Volar plating of distal radius fracture. Device: Aptus 2.5
PROCEDURE	Volar Plate Osteosynthesis Inteos 2.5	Volar plating of distal radius fracture. Device: Inteos 2.5

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-11-30
• Completion: 2022-02-28
• First posted: 2018-03-22
• Last updated: 2022-04-06

Locations

1 site across 1 country: Austria