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Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures

Primary Purpose

Forearm Pronation Strength Recovery

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pronator quadratus repair
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forearm Pronation Strength Recovery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • isolated, closed fractures of the distal radius
  • fractures type A2 to B2 according to the AO fracture classification system
  • primary volar locking plate osteosynthesis within 7 days after trauma

Exclusion Criteria:

  • concomitant fractures of the affected upper extremity
  • intra-articular distal radius fractures ( type C)
  • concomitant neurovascular injuries
  • preexisting neurological illnesses
  • initial external fixation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    PQ (Pronator quadraus) repair

    No PQ repair

    Arm Description

    Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture.

    Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair.

    Outcomes

    Primary Outcome Measures

    Isometric forearm pronation strength (N)
    Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
    Isometric forearm pronation strength (N)
    Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)

    Secondary Outcome Measures

    Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
    The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)
    Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
    The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)
    Visual analogue scale (VAS)
    Measurement of the pain level
    Visual analogue scale (VAS)
    Measurement of the pain level
    Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
    Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))
    Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
    Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))
    Assessment of the bilateral wrist motion (AO neutral-0-method)
    Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)
    Assessment of the bilateral wrist motion (AO neutral-0-method)
    Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)

    Full Information

    First Posted
    October 25, 2015
    Last Updated
    November 1, 2015
    Sponsor
    Technical University of Munich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02595229
    Brief Title
    Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures
    Official Title
    Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures or Not? - Results of a Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Technical University of Munich

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar plate fixation of distal radius fractures with regard to the forearm pronation strength. During the early recovery period of 3 months an improvement of pronation strength and functional scorings was hypothesized for the PQ repair when compared to no repair. Randomization of the patients in two groups ( PQ repair and no repair) and follow-up examinations after 6 and 12 weeks included bilateral isometric pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue scale (VAS)
    Detailed Description
    Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar plate fixation of distal radius fractures with special regards to the forearm pronation strength. During the early recovery period of 3 months an improvement of pronation strength and functional scorings was hypothesized for the PQ repair when compared to no repair. Therefore the patients are randomized to group A = PQ repair and group B = no repair. Follow-up examinations after 6 and 12 weeks are scheduled included bilateral isometric pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue scale (VAS)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Forearm Pronation Strength Recovery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PQ (Pronator quadraus) repair
    Arm Type
    Active Comparator
    Arm Description
    Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture.
    Arm Title
    No PQ repair
    Arm Type
    No Intervention
    Arm Description
    Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pronator quadratus repair
    Intervention Description
    Suturing of the pronator quadratus muscle
    Primary Outcome Measure Information:
    Title
    Isometric forearm pronation strength (N)
    Description
    Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
    Time Frame
    6 weeks postoperative
    Title
    Isometric forearm pronation strength (N)
    Description
    Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
    Time Frame
    12 weeks postoperative
    Secondary Outcome Measure Information:
    Title
    Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
    Description
    The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)
    Time Frame
    6 weeks postoperative
    Title
    Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
    Description
    The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)
    Time Frame
    12 weeks postoperative
    Title
    Visual analogue scale (VAS)
    Description
    Measurement of the pain level
    Time Frame
    6 weeks postoperative
    Title
    Visual analogue scale (VAS)
    Description
    Measurement of the pain level
    Time Frame
    12 weeks postoperative
    Title
    Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
    Description
    Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))
    Time Frame
    6 weeks postoperative
    Title
    Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
    Description
    Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))
    Time Frame
    12 weeks postoperative
    Title
    Assessment of the bilateral wrist motion (AO neutral-0-method)
    Description
    Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)
    Time Frame
    6 weeks postoperative
    Title
    Assessment of the bilateral wrist motion (AO neutral-0-method)
    Description
    Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)
    Time Frame
    12 weeks postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: isolated, closed fractures of the distal radius fractures type A2 to B2 according to the AO fracture classification system primary volar locking plate osteosynthesis within 7 days after trauma Exclusion Criteria: concomitant fractures of the affected upper extremity intra-articular distal radius fractures ( type C) concomitant neurovascular injuries preexisting neurological illnesses initial external fixation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sebastian Siebenlist, MD
    Organizational Affiliation
    Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gunther Sandmann, MD
    Organizational Affiliation
    Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26607745
    Citation
    Haberle S, Sandmann GH, Deiler S, Kraus TM, Fensky F, Torsiglieri T, Rondak IC, Biberthaler P, Stockle U, Siebenlist S. Pronator quadratus repair after volar plating of distal radius fractures or not? Results of a prospective randomized trial. Eur J Med Res. 2015 Nov 25;20:93. doi: 10.1186/s40001-015-0187-4.
    Results Reference
    derived

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    Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures

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