Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures

Not Applicable

Completed

• Conditions: Forearm Pronation Strength Recovery
• Interventions: Procedure: Pronator quadratus repair

• Registration Number: NCT02595229
• Lead Sponsor: Technical University of Munich

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)

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2015-10-25
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-01
• Last Update Submitted: 2015-11-01
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PQ (Pronator quadraus) repair	Pronator quadratus repair	Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture.

Primary Outcome Measures

Name	Time	Method
Isometric forearm pronation strength (N)	12 weeks postoperative	Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)

Secondary Outcome Measures

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