Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures

Study Overview
=================
Brief Summary
-----------------
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)

Detailed Description
-----------------
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)

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

Conditions
-----------------
Forearm Pronation Strength Recovery

Intervention / Treatment
-----------------
* Procedure: Pronator quadratus repair


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PQ (Pronator quadraus) repair<br>Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture. | Procedure: Pronator quadratus repair<br>* Suturing of the pronator quadratus muscle<br>|
| No Intervention: No PQ repair<br>Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric forearm pronation strength (N) | Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland) | 6 weeks postoperative | 
| Isometric forearm pronation strength (N) | Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland) | 12 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand) | The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia) | 6 weeks postoperative | 
| Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand) | The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia) | 12 weeks postoperative | 
| Visual analogue scale (VAS) | Measurement of the pain level | 6 weeks postoperative | 
| Visual analogue scale (VAS) | Measurement of the pain level | 12 weeks postoperative | 
| Mayo-Wrist-Score (Physician-based evaluation score of the wrist function) | Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work)) | 6 weeks postoperative | 
| Mayo-Wrist-Score (Physician-based evaluation score of the wrist function) | Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work)) | 12 weeks postoperative | 
| Assessment of the bilateral wrist motion (AO neutral-0-method) | Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension) | 6 weeks postoperative | 
| Assessment of the bilateral wrist motion (AO neutral-0-method) | Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension) | 12 weeks postoperative |