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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Nordsjaellands Hospital

Current Primary Outcome: Patient Rated Wrist Evaluation (PRWE) [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient Rated Wrist Evaluation (PRWE) [ Time Frame: 2 weeks, 5 weeks, 3 months, 6 months ]
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months ]
  • Pronation strength [ Time Frame: 5 weeks, 3 months, 6 months, 12 months ]
  • Grip strength [ Time Frame: 5 weeks, 3 months, 6 months, 12 months ]
  • Range of motion: supination/pronation [ Time Frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months ]
  • Operation time [ Time Frame: day 0 ]
  • Ultra sonic examination (Examination of tendons and PQ muscle) [ Time Frame: 3 months ]
    Examination of tendons and PQ muscle
  • Complications (Tendon rupture and Tendinitis) [ Time Frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months ]
    Tendon rupture and Tendinitis


Original Secondary Outcome: Same as current

Information By: Nordsjaellands Hospital

Dates:
Date Received: January 22, 2015
Date Started: February 2015
Date Completion: May 2017
Last Updated: September 8, 2016
Last Verified: September 2016