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

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

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.

Study Overview

• Status: Completed
• Conditions: Arm Injuries; Radius Fractures; Colles' Fracture; Rupture of Muscle
• Intervention / Treatment: Procedure: Repair; Procedure: Non-repair

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hilleroed, Denmark, 3400
    • Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repair; Repair of the pronator quadratus muscle	Procedure: Repair; An on-going suture technique with minimum four stitches.
Active Comparator: Non-repair; Non-repair of the pronator quadratus muscle	Procedure: Non-repair; The PQ muscle will be placed so it covers the volar plate. No suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Rated Wrist Evaluation (PRWE)	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: Jesper Sonntag, MD, Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery, Dyrehavevej 29, 3400 Hilleroed. Denmark

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Distal radius fracture; Repair; PRWE; Pronator quadratus; Volar plating
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Forearm Injuries; Fracture Dislocation; Rupture; Fractures, Bone; Radius Fractures; Colles' Fracture; Arm Injuries
• Other Study ID Numbers: PQ Project