Distal Radius Fractures, Internal Fixation; Complications, Mechanical
Conditions
Keywords
distal radius fractures, volar plate, internal fixation, Inmobilization
Brief summary
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.
Detailed description
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.
Interventions
DEVICESplint inmmobilization
After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks
DEVICEBandage immovilization
After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks
Sponsors
Hospital Costa del Sol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Patient receive the correspondant treatment based on the order of an aleatory numbers table
Intervention model description
2 parallel groups, each one receives one treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with type A, B, C fractures of AO classification of distal radius fractures * Patents aged between 18 and 75 years, * Patients operated on in the first 3 weeks after the trauma, and independent for the basic activities of daily living
Exclusion criteria
* Patients with open fractures * Patients with mental disorders (dementia, alcoholism, etc.), * Patient dependent for basic activities of daily living * Patients with fractures with severe articular and metaphyseal comminution and/or severe soft tissue injuries (type 2R3C3 AO), * Patients with previous diseases or anatomical alterations in the injured wrist (previous fractures, rheumatoid arthritis, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain in Visual Analogue Scale. | 1 year | Points from 1 to 10. Higher score: worse value. Lower score: better value. |
| Function in Patient Rated Wrist Evaluation Scale. | 1 year | Points from 1 to 100. Higher score: worse value. Lower score: better value. |
| Range Of Motion in Flexion. | 1 year | Grades from 0 to 70. Higher score: better value. Lower score: worse value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with posoperative complications. | 1 year | Number of participants per group that suffer some complication or side effect during the follow-up period. Higher number of complications: worse value. |
| Number of posoperative Fisiotherapy sessions performed. | 1 year | Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value. |
| Time of fracture union in radiographs. | 12 weeks | Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value. |
| Number of Instability distal radius fracture Criteria per participant. | 1 year | Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value. |
| Grades of Dorsal Displacement in fracture. | 6 weeks | Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value. |
| Function in Disabilities of Arm, Shoulder and Hand Scale. | 1 year | Points from 1 to 150. Higher score: worse value. Lower score: better value |
| Range of motion in Radial Deviation | 1 year | Grades from 0 to 15. Higher score: better value. Lower score: worse value. |
| Range of motion in Ulnar deviation. | 1 year | Grades from 0 to 30. Higher score: better value. Lower score: worse value. |
| Number of shortening millimeters in fracture. | 6 weeks | Number of millimeters from 0-10. Higher score: worse value. Lower score: better value. |
| Number of ulnar variance millimeters in fracture. | 6 weeks | Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value. |
| Number of step-off millimeters in fracture. | 6 weeks | Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value. |
| Range of motion in Pronation. | 1 year | Grades from 0 to 90. Higher score: better value. Lower score: worse value. |
| Function in Mayo Wrist Score Scale. | 1 year | Points from 1 to 100. Higher score: worse value. Lower score: better value. |
| Range of motion in Supination. | 1 year | Grades from 0 to 90. Higher score: better value. Lower score: worse value. |
Countries
Spain
Contacts
Primary ContactJose Ignacio Miró Jiménez, MD
Backup ContactAlberto Izquierdo Fernández, Phd
Outcome results
None listed