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

NCT02348437 | Completed

• 1 other identifier: PQ Project
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pronator quadratus; Distal radius fracture; Repair; Volar plating; PRWE

Outcome Measures

Primary Outcomes (1)

• Patient Rated Wrist Evaluation (PRWE)

  12 months

Secondary Outcomes (8)

• Patient Rated Wrist Evaluation (PRWE)

  2 weeks, 5 weeks, 3 months, 6 months

• Disabilities of the Arm, Shoulder and Hand (DASH)

  2 weeks, 5 weeks, 3 months, 6 months, 12 months

• Pronation strength

  5 weeks, 3 months, 6 months, 12 months

• Grip strength

  5 weeks, 3 months, 6 months, 12 months

• Range of motion: supination/pronation

  2 weeks, 5 weeks, 3 months, 6 months, 12 months

Study Arms (2)

Repair

EXPERIMENTAL

Repair of the pronator quadratus muscle

Procedure: Repair

Non-repair

ACTIVE COMPARATOR

Non-repair of the pronator quadratus muscle

Procedure: Non-repair

Interventions

Repair PROCEDURE

An on-going suture technique with minimum four stitches.

Repair

Non-repair PROCEDURE

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

Non-repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery

Hilleroed, 3400, Denmark

Location

MeSH Terms

Conditions

Radius Fractures; Colles' Fracture; Arm Injuries; Wrist Fractures

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Forearm Injuries; Wounds and Injuries; Fractures, Bone; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wrist Injuries

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Jesper Sonntag, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: January 28, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Locations

DK (1)