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

Sponsor

Nordsjaellands Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02348437

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Fractures Colles' Fracture Rupture of Muscle Arm Injuries	Procedure: Repair Procedure: Non-repair	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Repair Repair of the pronator quadratus muscle	Procedure: Repair An on-going suture technique with minimum four stitches.
Active Comparator: Non-repair Non-repair of the pronator quadratus muscle	Procedure: Non-repair The PQ muscle will be placed so it covers the volar plate. No suture.

Arm

Intervention/Treatment

Experimental: Repair

Repair of the pronator quadratus muscle

Procedure: Repair

An on-going suture technique with minimum four stitches.

Active Comparator: Non-repair

Non-repair of the pronator quadratus muscle

Procedure: Non-repair

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

Outcome Measures

Primary Outcome Measures

Patient Rated Wrist Evaluation (PRWE) [12 months]

Secondary Outcome Measures

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]
Operation time [day 0]
Ultra sonic examination (Examination of tendons and PQ muscle) [3 months]
Examination of tendons and PQ muscle
Complications (Tendon rupture and Tendinitis) [2 weeks, 5 weeks, 3 months, 6 months, 12 months]
Tendon rupture and Tendinitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.