Trial document




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  DRKS00006096

Trial Description

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Title

A new dissection and strong suture repair of the pronator quadratus muscle after volar
plate fixation at the distal radius: a prospective randomized study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In a prospective randomized study a new dissection and strong suture repair of the pronator quadratus muscle (PQ) in volar plate fixation of distal radius fractures will be compared with the conventional procedure

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Brief Summary in Scientific Language

In the treatment of distal radius fractures, volar locking plate fixation is an established procedure in which the pronator quadratus (PQ) muscle must be released to gain access to the distal radius. For two main reasons the muscle should be repaired. First, several studies have shown irritations or ruptures of the flexor tendons, which run nearly or actually in contact with the plate’s distal border after volar plate fixation of distal radius fractures. Coverage of the plate with the muscle protects the flexor tendons. Second, even though the patient may not be conscious of it loss of PQ function reduces pronation force up to 21%. Repair of the PQ maintains normal forearm pronation.
However, many surgeons do without a PQ repair. Suture repair of the PQ is not always satisfactory due to the muscle consistency. A radial incision through the muscle seldom enables a strong suture repair, and the PQ fascia is usually thin, making sutures likely to fail. Further complicating repair, in most cases a detached PQ muscle retracts and pulling it apart is often difficult or sometimes impossible, especially if the muscle is bloody due to the fracture haematoma.
Therefore, the aim of this study is to evaluate a new dissection and strong suture repair of the PQ in which the PQ is detached in conjunction with both a fibrous portion of the roof of the first extensor compartment and the common connection, tendinous insertion of the brachioradialis muscle/PQ after volar plate fixation of distal radius fractures in a prospective randomized study.

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Organizational Data

  •   DRKS00006096
  •   2014/07/11
  •   [---]*
  •   yes
  •   Approved
  •   14-106, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   S52.51 -  [generalization S52.5: Fracture of lower end of radius]
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Interventions/Observational Groups

  •   Repair of the pronator quadratus muscle with a part of the brachioradialis tendon
  •   Repair of the pronator quadratus muscle after incision through the muscle
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

End point of the study: Clinical and ultrasound evaluation of 17 patients in the trial and controll group respectively at one year follow-up

Primary outcome measure: Integrety of the pronator quadratus muscle

Measurements: range of motion of the wrist; grip force; pronation force; ultrasound of the pronator quadratus muscle; Disabilities of the Arm, Shoulder and Hand (DASH) and Mayo Wrist Score

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/07/21
  •   34
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Inclusion criteria: All patients between 18 and 90 years with simple extraarticular and intraarticular distal radius fractures

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Exclusion Criteria

Exclusion criteria: Childs under 18 years of age; complex distal radius fractures; additional required fixation materials beside the volar plate; additional approaches beside the volar approach; additional injuries; already operated at the respective distal radius

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Elbe Klinikum Stade
    • Mr.  Priv.-Doz. Dr. med.  Bernd  Hohendorff 
    • Bremervörder Straße 111
    • 21684  Stade
    • Germany
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    • Elbe Klinikum Stade
    • Mr.  Priv.-Doz. Dr. med.  Bernd  Hohendorff 
    • Bremervörder Straße 111
    • 21684  Stade
    • Germany
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    • Elbe Klinikum Stade
    • Mr.  Priv.-Doz. Dr. med.  Bernd  Hohendorff 
    • Bremervörder Straße 111
    • 21684  Stade
    • Germany
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Sources of Monetary or Material Support

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    • Elbe Klinikum Stade
    • Mr.  Priv.-Doz. Dr. med.  Bernd  Hohendorff 
    • Bremervörder Str. 111
    • 21684  Stade
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.