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Comparison of Two Volar Plating Systems for Distal Radius Fractures

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT03474445
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
60
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Volar Plate Osteosynthesis Aptus 2.5
  • Procedure: Volar Plate Osteosynthesis Inteos 2.5
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Two Volar Plating Systems for Distal Radius Fractures - A Prospective Randomized Single-blinded Controlled Clinical Trial
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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)

    3. strength measurement [4 weeks, 8 weeks, 3 months, 6 months, 12 months]

      dynamometer-based strength evaluation

    4. Volumetric evaluation [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Universtiy of Vienna Vienna Austria A-1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Haider, Principal Investigator, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT03474445
    Other Study ID Numbers:
    • 2339/2016
    First Posted:
    Mar 22, 2018
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fractures, Bone
    Radius Fractures

    Study Results

    No Results Posted as of Apr 6, 2022