Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures

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

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)

Study Overview

• Status: Completed
• Conditions: Forearm Pronation Strength Recovery
• Intervention / Treatment: Procedure: Pronator quadratus repair

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PQ (Pronator quadraus) repair; 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; Suturing of the pronator quadratus muscle
No Intervention: No PQ repair; 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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Sebastian Siebenlist, MD, Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München; Principal Investigator: Gunther Sandmann, MD, Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München

Publications and helpful links

General Publications

• Haberle S, Sandmann GH, Deiler S, Kraus TM, Fensky F, Torsiglieri T, Rondak IC, Biberthaler P, Stockle U, Siebenlist S. Pronator quadratus repair after volar plating of distal radius fractures or not? Results of a prospective randomized trial. Eur J Med Res. 2015 Nov 25;20:93. doi: 10.1186/s40001-015-0187-4.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: October 25, 2015
• First Submitted That Met QC Criteria: November 1, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 1, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Radius Fractures
• Other Study ID Numbers: 2759/10