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

Radius Fractures Clinical Trial

Official title:

Clinical Outcome After Repair of the Pronator Quadratus Muscle in Volar Locked Plating of the Distal Radius. A Randomised Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348437
• Other study ID #: PQ Project
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: August 31, 2017
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arm Injuries
• Colles' Fracture
• Fractures, Bone
• Radius Fractures
• Rupture
• Rupture of Muscle

Intervention

Procedure:
• Repair
An on-going suture technique with minimum four stitches.
• Non-repair
The PQ muscle will be placed so it covers the volar plate. No suture.

Locations

Country	Name	City	State
Denmark	Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery	Hilleroed

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Rated Wrist Evaluation (PRWE)		12 months
Secondary	Patient Rated Wrist Evaluation (PRWE)		2 weeks, 5 weeks, 3 months, 6 months
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH)		2 weeks, 5 weeks, 3 months, 6 months, 12 months
Secondary	Pronation strength		5 weeks, 3 months, 6 months, 12 months
Secondary	Grip strength		5 weeks, 3 months, 6 months, 12 months
Secondary	Range of motion: supination/pronation		2 weeks, 5 weeks, 3 months, 6 months, 12 months
Secondary	Operation time		day 0
Secondary	Ultra sonic examination (Examination of tendons and PQ muscle)	Examination of tendons and PQ muscle	3 months
Secondary	Complications (Tendon rupture and Tendinitis)	Tendon rupture and Tendinitis	2 weeks, 5 weeks, 3 months, 6 months, 12 months