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

Study Overview
=================
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 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.

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

Conditions
-----------------
Radius Fractures, Colles' Fracture, Rupture of Muscle, Arm Injuries

Intervention / Treatment
-----------------
* Procedure: Repair
* Procedure: Non-repair


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pronator quadratus, Distal radius fracture, Repair, Volar plating, PRWE