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Completed

NCT Number: NCT02348437

Repair vs Non-repair of the Pronator Quadratus Muscle in Distal Radius Fractures. RCT.

The purpose of this study is to determine the functional outcome of repairing the pronator quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar locked plating.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery

Hilleroed, 3400, Denmark

About this study

Fractures of the distal radius are common in the elderly. A frequent treatment of an unstable DRF is surgery with volar plating using the modified Henry's approach. In some cases the fracture mechanism has injured the PQ muscle and subsequent reconstruction of the muscle can be difficult. When the PQ muscle is not injured the plate is fixated through a radial and distal release of the PQ muscle and resuture/repair of the PQ muscle is attempted by most surgeons.

The clinical relevance of repairing the PQ muscle has not previously been investigated in a randomised clinical trial and we hypothesise that there is no difference in functional outcome whether the PQ muscle is repaired or not.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients over 18 years.
  • patients with an unstable DRF AO type 23 A2, A3, C1, C2 or C3 elected for surgery with volar plating. Unstable is defined as one of the following: 1) More than 10 degrees dorsal angulation of radius' joint surface in lateral plane measured from an orthogonal axis through radius. 2) Ulnar variance more than 2 mm. 3) Fracture line involving joint surface with more than 2 mm dislocation. 4) Incongruence of the DRJ.
  • patients that can undergo the surgery in plexus brachialis block (so the operation can be performed in the outpatient department).
  • patients with the ability to read and understand Danish.

Exclusion criteria

  • patients with an open fracture.
  • patients with a neurologic disorder affecting the fractured upper extremity.
  • patients with a history of fracture to the same wrist.
  • patients with dementia, substance abuse or severe psychiatric disorder.
  • patients who do not agree to be randomised.
  • patients unable to continue follow-up.

Treatment and study plan

Repair

Procedure

An on-going suture technique with minimum four stitches.

Non-repair

Procedure

The PQ muscle will be placed so it covers the volar plate. No suture.

Primary outcomes

  1. Patient Rated Wrist Evaluation (PRWE)

    Time frame: 12 months

Secondary outcomes

  1. Patient Rated Wrist Evaluation (PRWE)

    Time frame: 2 weeks, 5 weeks, 3 months, 6 months

  2. Disabilities of the Arm, Shoulder and Hand (DASH)

    Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months

  3. Pronation strength

    Time frame: 5 weeks, 3 months, 6 months, 12 months

  4. Grip strength

    Time frame: 5 weeks, 3 months, 6 months, 12 months

  5. Range of motion: supination/pronation

    Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months

  6. Operation time

    Time frame: day 0

  7. Ultra sonic examination (Examination of tendons and PQ muscle)

    Time frame: 3 months

    Examination of tendons and PQ muscle

  8. Complications (Tendon rupture and Tendinitis)

    Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months

    Tendon rupture and Tendinitis

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Official study title

Clinical Outcome After Repair of the Pronator Quadratus Muscle in Volar Locked Plating of the Distal Radius. A Randomised Clinical Trial.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2015
Registry last updated
Sep 1, 2017

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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