The aim of this study is to compare functional and radiological results in two groups of distal radius fractures treated with internal fixation with locking plate, and immobilized with antebrachial splint or compression bandage for 3 weeks.
The aim of the study is to compare functional and radiological results as well as to evaluate possible complications in distal radius fractures operated by open reduction and internal fixation with volar locking plate in two groups , one treated with immobilization using a forearm cast for 3 weeks and the other with immobilization using a compression bandage for 3 weeks, based on the hypothesis that compression bandage group could obtain better results in the short term, and none of the treatments is superior to the other after 3 or 6 months of evolution, as indicated by some reviewed studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks
After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks
Hospital Reina Sofía
Córdoba, Spain
RECRUITINGHospital Costa del Sol
Málaga, Spain
RECRUITINGPain in Visual Analogue Scale.
Points from 1 to 10. Higher score: worse value. Lower score: better value.
Time frame: 1 year
Function in Patient Rated Wrist Evaluation Scale.
Points from 1 to 100. Higher score: worse value. Lower score: better value.
Time frame: 1 year
Range Of Motion in Flexion.
Grades from 0 to 70. Higher score: better value. Lower score: worse value.
Time frame: 1 year
Range Of Motion in Flexion.
Grades from 0 to 80. Higher score: better value. Lower score: worse value.
Time frame: 1 year
Function in Disabilities of Arm, Shoulder and Hand Scale.
Points from 1 to 150. Higher score: worse value. Lower score: better value
Time frame: 1 year
Function in Mayo Wrist Score Scale.
Points from 1 to 100. Higher score: worse value. Lower score: better value.
Time frame: 1 year
Range of motion in Supination.
Grades from 0 to 90. Higher score: better value. Lower score: worse value.
Time frame: 1 year
Number of participants with posoperative complications.
Number of participants per group that suffer some complication or side effect during the follow-up period. Higher number of complications: worse value.
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Time frame: 1 year
Number of posoperative Fisiotherapy sessions performed.
Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value.
Time frame: 1 year
Time of fracture union in radiographs.
Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value.
Time frame: 12 weeks
Number of Instability distal radius fracture Criteria per participant.
Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value.
Time frame: 1 year
Grades of Dorsal Displacement in fracture.
Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value.
Time frame: 6 weeks
Range of motion in Pronation.
Grades from 0 to 90. Higher score: better value. Lower score: worse value.
Time frame: 1 year
Range of motion in Radial Deviation
Grades from 0 to 15. Higher score: better value. Lower score: worse value.
Time frame: 1 year
Range of motion in Ulnar deviation.
Grades from 0 to 30. Higher score: better value. Lower score: worse value.
Time frame: 1 year
Number of shortening millimeters in fracture.
Number of millimeters from 0-10. Higher score: worse value. Lower score: better value.
Time frame: 6 weeks
Number of ulnar variance millimeters in fracture.
Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value.
Time frame: 6 weeks
Number of step-off millimeters in fracture.
Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value.
Time frame: 6 weeks