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

Nordsjaellands Hospital72 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Radius Fractures Colles' Fracture Rupture of Muscle Arm Injuries

Interventions

RepairPROCEDURE

An on-going suture technique with minimum four stitches.

Non-repairPROCEDURE

The PQ muscle will be placed so it covers the volar plate. No suture.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery

Hilleroed, Denmark

Outcomes

Primary Outcomes

Patient Rated Wrist Evaluation (PRWE)

Time frame: 12 months

Secondary Outcomes

Patient Rated Wrist Evaluation (PRWE)

Time frame: 2 weeks, 5 weeks, 3 months, 6 months

Disabilities of the Arm, Shoulder and Hand (DASH)

Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months

Pronation strength

Time frame: 5 weeks, 3 months, 6 months, 12 months

Grip strength

Time frame: 5 weeks, 3 months, 6 months, 12 months

Range of motion: supination/pronation

Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months

Operation time

Time frame: day 0

Ultra sonic examination (Examination of tendons and PQ muscle)

Examination of tendons and PQ muscle

Time frame: 3 months

Complications (Tendon rupture and Tendinitis)

Tendon rupture and Tendinitis

Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months

Data from ClinicalTrials.gov

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