Comparison of Two Volar Plating Systems for Distal Radius Fractures

Not Applicable

Completed

• Conditions: Distal Radius Fracture
• Interventions: Procedure: Volar Plate Osteosynthesis Inteos 2.5; Procedure: Volar Plate Osteosynthesis Aptus 2.5

• Registration Number: NCT03474445
• Lead Sponsor: Medical University of Vienna

Brief 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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Primary Completion: 2021-11-30
• Study Completion: 2022-02-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Volar Plate Osteosynthesis Inteos 2.5	Volar Plate Osteosynthesis Inteos 2.5
Control group	Volar Plate Osteosynthesis Aptus 2.5	Volar Plate Osteosynthesis Aptus 2.5

Primary Outcome Measures

Name	Time	Method
Patient rated wrist evaluation	12 months	Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score

Secondary Outcome Measures

Name	Time	Method
Mayo wrist score	8 weeks, 3 months, 6 months, 12 months	Function-based evaluation of the wrist, range 0-100, 90-100=very good, 80-89=good, 65-79=satisfying, \<65=poor
Radiological Outcome	2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months	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)
Patient rated wrist evaluation	4 weeks, 8 weeks, 3 months, 6 months	Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score
strength measurement	4 weeks, 8 weeks, 3 months, 6 months, 12 months	dynamometer-based strength evaluation
Disabilities of the Arm, Shoulder and Hand, Outcome Score - DASH	4 weeks, 8 weeks, 3 months, 6 months, 12 months	patient-based standardised questionnaire, 30 items, range 0-100, 0=best outcome, 100=worst outcome
Volumetric evaluation	4 weeks, 8 weeks, 3 months, 6 months, 12 months	With a standardised device using water displacement wirst swelling will be assessed.

Trial Locations

Locations (1)

Medical Universtiy of Vienna; 🇦🇹 Vienna, Austria