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

Primary Purpose

Radius Fractures, Colles' Fracture, Rupture of Muscle

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Repair
Non-repair
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fractures focused on measuring Pronator quadratus, Distal radius fracture, Repair, Volar plating, PRWE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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.

Sites / Locations

  • Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Repair

Non-repair

Arm Description

Repair of the pronator quadratus muscle

Non-repair of the pronator quadratus muscle

Outcomes

Primary Outcome Measures

Patient Rated Wrist Evaluation (PRWE)

Secondary Outcome Measures

Patient Rated Wrist Evaluation (PRWE)
Disabilities of the Arm, Shoulder and Hand (DASH)
Pronation strength
Grip strength
Range of motion: supination/pronation
Operation time
Ultra sonic examination (Examination of tendons and PQ muscle)
Examination of tendons and PQ muscle
Complications (Tendon rupture and Tendinitis)
Tendon rupture and Tendinitis

Full Information

First Posted
January 22, 2015
Last Updated
August 31, 2017
Sponsor
Nordsjaellands Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02348437
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nordsjaellands Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures, Colles' Fracture, Rupture of Muscle, Arm Injuries
Keywords
Pronator quadratus, Distal radius fracture, Repair, Volar plating, PRWE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repair
Arm Type
Experimental
Arm Description
Repair of the pronator quadratus muscle
Arm Title
Non-repair
Arm Type
Active Comparator
Arm Description
Non-repair of the pronator quadratus muscle
Intervention Type
Procedure
Intervention Name(s)
Repair
Intervention Description
An on-going suture technique with minimum four stitches.
Intervention Type
Procedure
Intervention Name(s)
Non-repair
Intervention Description
The PQ muscle will be placed so it covers the volar plate. No suture.
Primary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation (PRWE)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation (PRWE)
Time Frame
2 weeks, 5 weeks, 3 months, 6 months
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame
2 weeks, 5 weeks, 3 months, 6 months, 12 months
Title
Pronation strength
Time Frame
5 weeks, 3 months, 6 months, 12 months
Title
Grip strength
Time Frame
5 weeks, 3 months, 6 months, 12 months
Title
Range of motion: supination/pronation
Time Frame
2 weeks, 5 weeks, 3 months, 6 months, 12 months
Title
Operation time
Time Frame
day 0
Title
Ultra sonic examination (Examination of tendons and PQ muscle)
Description
Examination of tendons and PQ muscle
Time Frame
3 months
Title
Complications (Tendon rupture and Tendinitis)
Description
Tendon rupture and Tendinitis
Time Frame
2 weeks, 5 weeks, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Sonntag, MD
Organizational Affiliation
Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery, Dyrehavevej 29, 3400 Hilleroed. Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery
City
Hilleroed
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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