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

NCT ID: NCT02348437

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Repair

Repair of the pronator quadratus muscle

Group Type: EXPERIMENTAL

Repair

Intervention Type: PROCEDURE

An on-going suture technique with minimum four stitches.

Non-repair

Non-repair of the pronator quadratus muscle

Group Type: ACTIVE_COMPARATOR

Non-repair

Intervention Type: PROCEDURE

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

Interventions

Repair

An on-going suture technique with minimum four stitches.

Intervention Type: PROCEDURE

Non-repair

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jesper Sonntag

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesper Sonntag, MD

Role: PRINCIPAL_INVESTIGATOR

Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery, Dyrehavevej 29, 3400 Hilleroed. Denmark

Locations

Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery

Hilleroed, , Denmark

Countries

Denmark

Other Identifiers

PQ Project

Identifier Type: -

Identifier Source: org_study_id