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

Not Applicable

Completed

• Conditions: Radius Fractures; Arm Injuries; Rupture of Muscle; Colles' Fracture
• Interventions: Procedure: Repair; Procedure: Non-repair

• Registration Number: NCT02348437
• Lead Sponsor: Nordsjaellands Hospital

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.

Study Timeline

• Study First Submitted: 2015-01-22
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Study Start: 2015-02
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repair	Repair	Repair of the pronator quadratus muscle
Non-repair	Non-repair	Non-repair of the pronator quadratus muscle

Primary Outcome Measures

Name	Time	Method
Patient Rated Wrist Evaluation (PRWE)	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery; 🇩🇰 Hilleroed, Denmark