Clinical trial NCT02348437: Repair vs Non-repair of the Pronator Quadratus Muscle in Distal Radius Fractures. RCT.
Official title: Clinical Outcome After Repair of the Pronator Quadratus Muscle in Volar Locked Plating of the Distal Radius. A Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fractures
Colles' Fracture
Rupture of Muscle
Arm Injuries
Keywords: Pronator quadratus
Distal radius fracture
Repair
Volar plating
PRWE
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: 12 months
Secondary outcomes:
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: 2 weeks, 5 weeks, 3 months, 6 months
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months
measure: Pronation strength
timeFrame: 5 weeks, 3 months, 6 months, 12 months
measure: Grip strength
timeFrame: 5 weeks, 3 months, 6 months, 12 months
measure: Range of motion: supination/pronation
timeFrame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months
measure: Operation time
timeFrame: day 0
measure: Ultra sonic examination (Examination of tendons and PQ muscle)
timeFrame: 3 months
measure: Complications (Tendon rupture and Tendinitis)
timeFrame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Hilleroed
country: Denmark
facility: Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery
Study officials:
affiliation: Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery, Dyrehavevej 29, 3400 Hilleroed. Denmark
name: Jesper Sonntag, MD
role: PRINCIPAL_INVESTIGATOR
References: