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

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Volar Plate Osteosynthesis Aptus 2.5; Procedure: Volar Plate Osteosynthesis Inteos 2.5

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • Medical Universtiy of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Volar Plate Osteosynthesis Aptus 2.5	Procedure: Volar Plate Osteosynthesis Aptus 2.5; Volar plating of distal radius fracture. Device: Aptus 2.5; Other Names: Henry approach, cutting of pronator quadratus
Active Comparator: Study Group; Volar Plate Osteosynthesis Inteos 2.5	Procedure: Volar Plate Osteosynthesis Inteos 2.5; Volar plating of distal radius fracture. Device: Inteos 2.5; Other Names: Henry approach, preservation of pronator quadratus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
strength measurement	dynamometer-based strength evaluation	4 weeks, 8 weeks, 3 months, 6 months, 12 months
Volumetric evaluation	With a standardised device using water displacement wirst swelling will be assessed.	4 weeks, 8 weeks, 3 months, 6 months, 12 months
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
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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Thomas Haider, M.D., Ph.D., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 2339/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No