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Completed

NCT Number: NCT02595229

Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures

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)

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Key information

Conditions

Forearm Pronation Strength Recovery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pronator quadratus repair

Procedure

Suturing of the pronator quadratus muscle

Primary outcomes

  1. Isometric forearm pronation strength (N)

    Time frame: 6 weeks postoperative

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

  2. Isometric forearm pronation strength (N)

    Time frame: 12 weeks postoperative

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

Secondary outcomes

  1. Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)

    Time frame: 6 weeks postoperative

    The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)

  2. Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)

    Time frame: 12 weeks postoperative

    The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)

  3. Visual analogue scale (VAS)

    Time frame: 6 weeks postoperative

    Measurement of the pain level

  4. Visual analogue scale (VAS)

    Time frame: 12 weeks postoperative

    Measurement of the pain level

  5. Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)

    Time frame: 6 weeks postoperative

    Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))

  6. Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)

    Time frame: 12 weeks postoperative

    Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))

  7. Assessment of the bilateral wrist motion (AO neutral-0-method)

    Time frame: 6 weeks postoperative

    Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)

  8. Assessment of the bilateral wrist motion (AO neutral-0-method)

    Time frame: 12 weeks postoperative

    Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures or Not? - Results of a Prospective Randomized Trial

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 3, 2015
Registry last updated
Nov 3, 2015

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.