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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02348437 |
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Date of registration:
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22/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Repair vs Non-repair of the Pronator Quadratus Muscle in Distal Radius Fractures. RCT.
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Scientific title:
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Clinical Outcome After Repair of the Pronator Quadratus Muscle in Volar Locked Plating of the Distal Radius. A Randomised Clinical Trial. |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02348437 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jesper Sonntag, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery, Dyrehavevej 29, 3400 Hilleroed. Denmark |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arm Injuries
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Radius Fractures
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Rupture of Muscle
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Colles' Fracture
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Intervention(s)
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Procedure: Non-repair
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Procedure: Repair
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Primary Outcome(s)
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Patient Rated Wrist Evaluation (PRWE)
[Time Frame: 12 months]
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Secondary Outcome(s)
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Grip strength
[Time Frame: 5 weeks, 3 months, 6 months, 12 months]
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Pronation strength
[Time Frame: 5 weeks, 3 months, 6 months, 12 months]
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Ultra sonic examination (Examination of tendons and PQ muscle)
[Time Frame: 3 months]
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Operation time
[Time Frame: day 0]
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Disabilities of the Arm, Shoulder and Hand (DASH)
[Time Frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months]
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Range of motion: supination/pronation
[Time Frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months]
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Complications (Tendon rupture and Tendinitis)
[Time Frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months]
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Patient Rated Wrist Evaluation (PRWE)
[Time Frame: 2 weeks, 5 weeks, 3 months, 6 months]
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Secondary ID(s)
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PQ Project
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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