An interventional study of Splint inmmobilization and Bandage immovilization in Distal Radius Fractures and Internal Fixation; Complications, Mechanical, sponsored by Hospital Costa del Sol. Recruiting at 2 sites in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Hospital Costa del Sol · Not applicable, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 120 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Hospital Costa del Sol is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Distal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks
Device: Splint inmmobilization
Distal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks
Device: Bandage immovilization
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
Pain 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.
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
Plan to share: No
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Hospital Costa del Sol