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

Nordsjaellands Hospital

Status: Completed

Conditions: Radius Fractures; Colles' Fracture; Arm Injuries; Rupture of Muscle

Treatments: Procedure: Non-repair; Procedure: Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT02348437

PQ Project

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Repair

Experimental group

Description:

Repair of the pronator quadratus muscle

Treatment:

Procedure: Repair

Non-repair

Active Comparator group

Description:

Non-repair of the pronator quadratus muscle

Treatment:

Procedure: Non-repair