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| ID | Type | Description | Link |
|---|---|---|---|
| 1166CESC | Registry Identifier | Comitato Etico per la sperimentazione clinica delle province di Verona e Rovigo |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short arm cast | Experimental | Patient treated with below-elbow cast |
|
| Long arm cast | Active Comparator | Patients treated with above-elbow cast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short arm cast | Procedure | Application of a below-elbow cast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Secondary displacement ratio | Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators. | 35 days |
| Variation of radial length | Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs. | 35 days |
| Variation of radial inclination | Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs. | 35 days |
| Variation of volar tilt | Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs. | 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-treatment elbow range of motion (ROM) | Degrees of extension, flexion, pronation and supination of the elbow measured at the end of the treatment. | 35 days |
| DASH score | Disability of Arm, Shoulder and Hand score measured at the end of the treatment relating to patient's comfort during treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tommaso Maluta, MD | Azienda Ospedaliera Universitaria Integrata Verona | Study Director |
| Giovanni Dib, MD | Azienda Ospedaliera Universitaria Integrata Verona | Principal Investigator |
| Matteo Cengarle, MD | Azienda Ospedaliera Universitaria Integrata Verona | Principal Investigator |
| Alice Bernasconi, DR | Azienda Ospedaliera Universitaria Integrata Verona | Principal Investigator |
| Franco Lavini, MD | Azienda Ospedaliera Universitaria Integrata Verona | Principal Investigator |
| Andrea Scalvi, MD | Azienda Ospedaliera Universitaria Integrata Verona | Study Chair |
| Bruno Magnan, MD | Azienda Ospedaliera Universitaria Integrata Verona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Civile Maggiore Borgo Trento | Verona | 37126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36189333 | Derived | Dib G, Maluta T, Cengarle M, Bernasconi A, Marconato G, Corain M, Magnan B. Short arm cast is as effective as long arm cast in maintaining distal radius fracture reduction: Results of the SLA-VER noninferiority trial. World J Orthop. 2022 Sep 18;13(9):802-811. doi: 10.5312/wjo.v13.i9.802. eCollection 2022 Sep 18. |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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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%.
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| Long arm cast | Procedure | Application of an above-elbow cast |
|
|
| 35 days |
| SF-12 | Short Form 12 health questionnaire administered at the end of the treatment relating to patient's quality of life during treatment. | 35 days |