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NCT Number: NCT03474445

Comparison of Two Volar Plating Systems for Distal Radius Fractures

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Universtiy of Vienna

Vienna, A-1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volar Plate Osteosynthesis Aptus 2.5

Procedure

Volar plating of distal radius fracture. Device: Aptus 2.5

Other names: Henry approach, cutting of pronator quadratus

Volar Plate Osteosynthesis Inteos 2.5

Procedure

Volar plating of distal radius fracture. Device: Inteos 2.5

Other names: Henry approach, preservation of pronator quadratus

Primary outcomes

  1. Patient rated wrist evaluation

    Time frame: 12 months

    Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score

Secondary outcomes

  1. Mayo wrist score

    Time frame: 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

  2. Radiological Outcome

    Time frame: 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)

  3. strength measurement

    Time frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months

    dynamometer-based strength evaluation

  4. Volumetric evaluation

    Time frame: 4 weeks, 8 weeks, 3 months, 6 months, 12 months

    With a standardised device using water displacement wirst swelling will be assessed.

  5. Disabilities of the Arm, Shoulder and Hand, Outcome Score - DASH

    Time frame: 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

  6. Patient rated wrist evaluation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Mar 22, 2018
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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