Radius Fracture Distal
Conditions
Keywords
Cast treatment, above-elbow cast, below-elbow cast, long arm cast, short arm cast
Brief summary
This study prospectively compares the performance of an above-elbow cast (long arm cast) and a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal radius fractures.
Detailed description
The choice of cast length in conservative management of distal radius fractures still represents a much debated controversy. Classic teaching was to immobilize the elbow to reduce risk of secondary displacement; however, short arm casts are felt to be equally effective with less complications and higher patient comfort. There is currently no conclusive evidence for or against immobilization of the elbow in patients treated with cast immobilization.
Interventions
PROCEDUREShort arm cast
Application of a below-elbow cast
PROCEDURELong arm cast
Application of an above-elbow cast
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Non-inferiority trial aimed at comparing the non inferiority of a short arm cast (below elbow cast) as opposed to a long arm cast (below elbow cast) in terms of fracture reduction maintenance ratio. The sample size was selected as the highest required to test all non-inferiority thresholds and considering a drop-out percentage of 15%. Continuous values of all radiological parameters were used in order to keep results objective and reproducible. At the end of recruitment observed drop-out percentage was 26%.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of distal radius fracture * Indication to conservative treatment * Need for manipulation to reduce fracture
Exclusion criteria
* Open fractures * Existence of any skin lesion or wound that would impair cast treatment * Neurovascular deficits * Bilateral fractures * Association with any other fracture of the homolateral arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary displacement ratio | 35 days | Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators. |
| Variation of radial length | 35 days | Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs. |
| Variation of radial inclination | 35 days | Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs. |
| Variation of volar tilt | 35 days | Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DASH score | 35 days | Disability of Arm, Shoulder and Hand score measured at the end of the treatment relating to patient's comfort during treatment. |
| SF-12 | 35 days | Short Form 12 health questionnaire administered at the end of the treatment relating to patient's quality of life during treatment. |
| Post-treatment elbow range of motion (ROM) | 35 days | Degrees of extension, flexion, pronation and supination of the elbow measured at the end of the treatment. |
Countries
Italy
Outcome results
None listed