Comparison of Two Volar Plating Systems for Distal Radius Fractures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Procedure: Volar Plate Osteosynthesis Aptus 2.5
* Procedure: Volar Plate Osteosynthesis Inteos 2.5


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |