Below-Elbow Versus Initial Above-Elbow Casting for Distal Radius Fractures
11 luglio 2026 aggiornato da: Alper Sukru Kendirci, Istanbul University
Below-Elbow Versus Initial Above-Elbow Casting After Closed Reduction of Distal Radius Fractures: 12-Week Isokinetic and 5-Year Functional Outcomes of a Prospective Randomized Trial
The goal of this clinical trial was to compare two casting strategies for adults with a broken wrist, also called a distal radius fracture. The study included people whose treating team had determined that treatment without surgery was appropriate. Their fracture was first put back into position without surgery.
The main questions were:
- Does starting treatment with a below-elbow cast or an above-elbow cast affect how well the fracture stays in position?
- Does cast length affect early elbow or shoulder pain and stiffness?
- Does it affect grip strength, arm and wrist muscle recovery, wrist function, or long-term disability?
Researchers compared a below-elbow cast used from the start with an above-elbow cast used for the first 2 weeks and then changed to a below-elbow cast.
Participants:
- were randomly assigned to one of the two casting strategies
- wore a cast for 4 weeks, followed by a splint and rehabilitation
- had x-rays and clinical assessments during the first 12 weeks
- were scheduled for bilateral grip-strength and machine-based muscle-strength testing at cast removal and at 12 weeks
- were invited to complete a clinical and functional follow-up assessment at approximately 5 years
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
Distal radius fractures that are suitable for nonsurgical care are commonly treated with closed reduction and cast immobilization. Whether the elbow should be immobilized during the early treatment period remains uncertain. Above-elbow casting may restrict forearm rotation and theoretically improve fracture stability, but it may also cause elbow and shoulder discomfort or stiffness. Below-elbow casting preserves elbow movement and may reduce this treatment burden.
This was a single-center, prospective, randomized, parallel-group clinical trial involving adults aged 18 to 70 years with eligible AO/OTA distal radius fractures. After the treating team established that nonsurgical treatment was indicated, participants underwent closed reduction and were assigned by web-based block randomization to one of two cast-immobilization strategies. Randomization therefore occurred after the indication for nonsurgical treatment had been established, not after nonsurgical treatment had been completed.
Participants assigned to the below-elbow casting group received a below-elbow cast immediately after reduction. Participants assigned to the initial above-elbow casting group received an above-elbow cast immediately after reduction. At 2 weeks, the above-elbow cast was converted to a below-elbow cast. Cast immobilization ended at 4 weeks in both groups, followed by wrist splinting and rehabilitation.
At the initial injury assessment on Day 1, grip-strength testing and Cybex isokinetic testing were performed only on the uninjured contralateral upper extremity. Bilateral grip-strength and Cybex assessments were performed at cast removal, 4 weeks after closed reduction, and again at 12 weeks. Cybex measurements included raw peak torque, peak torque normalized to body weight, raw work per repetition, work per repetition normalized to body weight, and range of motion during elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation. Side-to-side deficits were derived from the bilateral assessments at 4 and 12 weeks.
Radiographic follow-up included measurement of radial inclination, radial height, ulnar variance, and volar tilt immediately after reduction, at 4 weeks, and at 12 weeks. Maintenance of reduction was evaluated as within-participant change in these radiographic parameters through 12 weeks. Early clinical outcomes included elbow or shoulder pain and stiffness at cast removal, grip-strength recovery, and patient-reported wrist and upper-extremity function. Complications, additional treatment, and conversion to surgery were monitored through the 12-week follow-up period.
Patient-reported outcomes included the Patient-Rated Wrist and Hand Evaluation and the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. These measures were assessed during early follow-up and again at approximately 5 years. The long-term assessment also included treatment satisfaction. The 5-year assessment was limited to clinical and functional outcomes; Cybex isokinetic testing was not repeated at 5 years.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
93
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Istanbul, Turchia (Türkiye), 34093
- Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Age 18 to 70 years
- Closed distal radius fracture for which the treating team determined that nonsurgical treatment with closed reduction and cast immobilization was appropriate
- AO/OTA distal radius fracture classified as 2R3A2, 2R3A3, 2R3B2, 2R3B3, 2R3C1, 2R3C2, or 2R3C3
Exclusion Criteria:
- AO/OTA distal radius fracture classified as 2R3A1 or 2R3B1
- Open distal radius fracture
- History of an allergic reaction to cast material
- Previous surgery involving the wrist or elbow
- Distal radius fracture judged to require operative treatment at the initial evaluation
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Below-Elbow Cast
After nonoperative treatment was determined to be appropriate and closed reduction was completed, participants received a below-elbow cast.
Cast immobilization continued for 4 weeks, after which the cast was removed and splinting and rehabilitation were started.
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A below-elbow cast was applied following closed reduction of the distal radius fracture.
The cast was maintained until 4 weeks after reduction and was then removed.
Splinting and rehabilitation followed cast removal.
Altri nomi:
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Comparatore attivo: Initial Above-Elbow Cast
After nonoperative treatment was determined to be appropriate and closed reduction was completed, participants received an above-elbow cast.
At 2 weeks, the cast was converted to a below-elbow cast.
All cast immobilization ended at 4 weeks, followed by splinting and rehabilitation.
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An above-elbow cast was applied following closed reduction of the distal radius fracture.
At 2 weeks, the above-elbow cast was converted to a below-elbow cast.
All cast immobilization ended at 4 weeks after reduction, followed by splinting and rehabilitation.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
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Peak torque measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded separately for the affected and unaffected upper extremities.
Higher values indicate greater strength relative to body weight.
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12 weeks after closed reduction
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Raw Isokinetic Peak Torque at Cast Removal
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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Bilateral Cybex isokinetic dynamometry measured raw peak torque during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded separately for the affected and unaffected upper extremities in newton-meters.
Higher values indicate greater maximal isokinetic strength.
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At cast removal, 4 weeks after closed reduction
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Raw Isokinetic Peak Torque at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
|
Bilateral Cybex isokinetic dynamometry measured raw peak torque during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded separately for the affected and unaffected upper extremities in newton-meters.
Higher values indicate greater maximal isokinetic strength.
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12 weeks after closed reduction
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Isokinetic Peak Torque Normalized to Body Weight at Cast Removal
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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Peak torque measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded separately for the affected and unaffected upper extremities.
Higher values indicate greater strength relative to body weight.
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At cast removal, 4 weeks after closed reduction
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Raw Isokinetic Work per Repetition at Cast Removal
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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Bilateral Cybex isokinetic dynamometry measured raw work per repetition during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded separately for the affected and unaffected upper extremities in newton-meters.
Higher values indicate greater work performed per repetition.
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At cast removal, 4 weeks after closed reduction
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Isokinetic Work per Repetition Normalized to Body Weight at Cast Removal
Lasso di tempo: At cast removal, 4 weeks after closed reduction
|
Work per repetition measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded separately for the affected and unaffected upper extremities.
Higher values indicate greater work capacity relative to body weight.
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At cast removal, 4 weeks after closed reduction
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Isokinetic Range of Motion at Cast Removal
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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Bilateral range-of-motion values were recorded in degrees during Cybex testing for elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation.
Values were recorded separately for the affected and unaffected upper extremities.
Positive or negative values could be recorded according to the directional convention of the dynamometer.
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At cast removal, 4 weeks after closed reduction
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Affected-to-Unaffected Isokinetic Deficit at Cast Removal
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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Affected-to-unaffected side deficits were calculated separately for raw peak torque, peak torque normalized to body weight, raw work per repetition, work per repetition normalized to body weight, and range of motion across the tested movements.
Deficits were expressed as percentages relative to the unaffected side.
Higher positive values indicate a greater deficit of the affected side; 0% indicates no side-to-side difference.
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At cast removal, 4 weeks after closed reduction
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Bilateral Grip Strength at Cast Removal
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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Grip strength was measured in kilograms using a hand dynamometer.
Three trials were recorded separately for the affected and unaffected hands.
Higher values indicate greater grip strength.
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At cast removal, 4 weeks after closed reduction
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Raw Isokinetic Work per Repetition at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
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Bilateral Cybex isokinetic dynamometry measured raw work per repetition during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded separately for the affected and unaffected upper extremities in newton-meters.
Higher values indicate greater work performed per repetition.
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12 weeks after closed reduction
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Isokinetic Work per Repetition Normalized to Body Weight at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
|
Work per repetition measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded separately for the affected and unaffected upper extremities.
Higher values indicate greater work capacity relative to body weight.
|
12 weeks after closed reduction
|
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Isokinetic Range of Motion at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
|
Bilateral range-of-motion values were recorded in degrees during Cybex testing for elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation.
Values were recorded separately for the affected and unaffected upper extremities.
Positive or negative values could be recorded according to the directional convention of the dynamometer.
|
12 weeks after closed reduction
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Affected-to-Unaffected Isokinetic Deficit at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
|
Affected-to-unaffected side deficits were calculated separately for raw peak torque, peak torque normalized to body weight, raw work per repetition, work per repetition normalized to body weight, and range of motion across the tested movements.
Deficits were expressed as percentages relative to the unaffected side.
Higher positive values indicate a greater deficit of the affected side; 0% indicates no side-to-side difference.
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12 weeks after closed reduction
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Bilateral Grip Strength at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
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Grip strength was measured in kilograms using a hand dynamometer.
Three trials were recorded separately for the affected and unaffected hands.
Higher values indicate greater grip strength.
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12 weeks after closed reduction
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Change in Affected-Hand Grip Strength From 4 to 12 Weeks
Lasso di tempo: 4 and 12 weeks after closed reduction
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Grip strength of the affected hand was measured in kilograms using a hand dynamometer at 4 and 12 weeks.
The analysis value at each assessment was derived from the recorded grip-strength trials.
Change was calculated as the 12-week value minus the 4-week value.
Positive values indicate improvement in affected-hand grip strength.
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4 and 12 weeks after closed reduction
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Change in Radial Inclination From Post-Reduction to 12 Weeks
Lasso di tempo: Immediately after closed reduction and 12 weeks after closed reduction
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Radial inclination was measured in degrees on anteroposterior wrist radiographs immediately after closed reduction and at 12 weeks.
Change was calculated as the 12-week value minus the immediate post-reduction value.
A negative change indicates loss of radial inclination.
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Immediately after closed reduction and 12 weeks after closed reduction
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Change in Radial Height From Post-Reduction to 12 Weeks
Lasso di tempo: Immediately after closed reduction and 12 weeks after closed reduction
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Radial height was measured in millimeters on anteroposterior wrist radiographs immediately after closed reduction and at 12 weeks.
Change was calculated as the 12-week value minus the immediate post-reduction value.
A negative change indicates loss of radial height.
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Immediately after closed reduction and 12 weeks after closed reduction
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Change in Ulnar Variance From Post-Reduction to 12 Weeks
Lasso di tempo: Immediately after closed reduction and 12 weeks after closed reduction
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Ulnar variance was measured in millimeters on anteroposterior wrist radiographs immediately after closed reduction and at 12 weeks.
Change was calculated as the 12-week value minus the immediate post-reduction value.
A positive change indicates increased positive ulnar variance.
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Immediately after closed reduction and 12 weeks after closed reduction
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Change in Volar Tilt From Post-Reduction to 12 Weeks
Lasso di tempo: Immediately after closed reduction and 12 weeks after closed reduction
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Volar tilt was measured in degrees on lateral wrist radiographs immediately after closed reduction and at 12 weeks.
Change was calculated as the 12-week value minus the immediate post-reduction value.
A negative change indicates loss of volar tilt or progression toward dorsal tilt.
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Immediately after closed reduction and 12 weeks after closed reduction
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Elbow or Shoulder Pain and Stiffness at Cast Removal
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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Participants rated elbow or shoulder pain and stiffness using a numeric scale from 0 to 10.
A score of 0 indicates no elbow or shoulder pain or stiffness.
Higher scores indicate greater symptom severity.
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At cast removal, 4 weeks after closed reduction
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Patient-Rated Wrist and Hand Evaluation Total Score at 4 Weeks
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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The Patient-Rated Wrist and Hand Evaluation is a 15-item participant-reported questionnaire assessing wrist and hand pain and disability.
The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
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At cast removal, 4 weeks after closed reduction
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Patient-Rated Wrist and Hand Evaluation Total Score at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
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The Patient-Rated Wrist and Hand Evaluation is a 15-item participant-reported questionnaire assessing wrist and hand pain and disability.
The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
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12 weeks after closed reduction
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Quick Disabilities of the Arm, Shoulder and Hand Total Score at 4 Weeks
Lasso di tempo: At cast removal, 4 weeks after closed reduction
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The 11-item Quick Disabilities of the Arm, Shoulder and Hand questionnaire assesses upper-extremity symptoms and disability.
The total score ranges from 0 to 100, with higher scores indicating greater disability.
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At cast removal, 4 weeks after closed reduction
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Quick Disabilities of the Arm, Shoulder and Hand Total Score at 12 Weeks
Lasso di tempo: 12 weeks after closed reduction
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The 11-item Quick Disabilities of the Arm, Shoulder and Hand questionnaire assesses upper-extremity symptoms and disability.
The total score ranges from 0 to 100, with higher scores indicating greater disability.
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12 weeks after closed reduction
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Number of Participants With Complications or Additional Treatment Through 12 Weeks
Lasso di tempo: From closed reduction through 12 weeks after closed reduction
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Number of participants with at least one cast-related or fracture-related complication, repeat reduction, conversion to surgery, unplanned change in immobilization, or other additional treatment during the first 12 weeks after closed reduction.
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From closed reduction through 12 weeks after closed reduction
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Patient-Rated Wrist and Hand Evaluation Total Score at 5 Years
Lasso di tempo: 5 years after closed reduction
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The Patient-Rated Wrist and Hand Evaluation is a 15-item participant-reported questionnaire assessing wrist and hand pain and disability.
The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
|
5 years after closed reduction
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Quick Disabilities of the Arm, Shoulder and Hand Total Score at 5 Years
Lasso di tempo: 5 years after closed reduction
|
The 11-item Quick Disabilities of the Arm, Shoulder and Hand questionnaire assesses upper-extremity symptoms and disability.
The total score ranges from 0 to 100, with higher scores indicating greater disability.
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5 years after closed reduction
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Treatment Satisfaction Score at 5 Years
Lasso di tempo: 5 years after closed reduction
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Participants rated their satisfaction with the assigned casting treatment on a scale from 0 to 5. Higher scores indicate greater treatment satisfaction.
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5 years after closed reduction
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Contralateral Raw Isokinetic Peak Torque at the Initial Injury Assessment
Lasso di tempo: At the initial injury assessment (Day 1)
|
Cybex isokinetic dynamometry measured raw peak torque of the uninjured contralateral upper extremity during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded in newton-meters.
Higher values indicate greater maximal isokinetic strength.
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At the initial injury assessment (Day 1)
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Contralateral Isokinetic Peak Torque Normalized to Body Weight at the Initial Injury Assessment
Lasso di tempo: At the initial injury assessment (Day 1)
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Peak torque of the uninjured contralateral upper extremity was measured using Cybex isokinetic dynamometry, normalized to body weight, and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Higher values indicate greater strength relative to body weight.
|
At the initial injury assessment (Day 1)
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Contralateral Raw Isokinetic Work per Repetition at the Initial Injury Assessment
Lasso di tempo: At the initial injury assessment (Day 1)
|
Cybex isokinetic dynamometry measured raw work per repetition of the uninjured contralateral upper extremity during elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Values were recorded in newton-meters.
Higher values indicate greater work performed per repetition.
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At the initial injury assessment (Day 1)
|
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Contralateral Isokinetic Work per Repetition Normalized to Body Weight at the Initial Injury Assessment
Lasso di tempo: At the initial injury assessment (Day 1)
|
Work per repetition of the uninjured contralateral upper extremity was measured using Cybex isokinetic dynamometry, normalized to body weight, and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation.
Higher values indicate greater work capacity relative to body weight.
|
At the initial injury assessment (Day 1)
|
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Contralateral Isokinetic Range of Motion at the Initial Injury Assessment
Lasso di tempo: At the initial injury assessment (Day 1)
|
Range-of-motion values of the uninjured contralateral upper extremity were recorded in degrees during Cybex testing for elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation.
Positive or negative values could be recorded according to the directional convention of the dynamometer.
|
At the initial injury assessment (Day 1)
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Contralateral Grip Strength at the Initial Injury Assessment
Lasso di tempo: At the initial injury assessment (Day 1)
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Grip strength of the uninjured contralateral hand was measured in kilograms using a hand dynamometer.
Three grip-strength trials were recorded.
Higher values indicate greater grip strength.
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At the initial injury assessment (Day 1)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Alper Ş. Kendirci, M.D., Istanbul University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Chaudhry YP, Morway GR, Papadelis EA, Doerr NA, Graf KW, Mashru RP, Dolch HJ. Comparison of Short-Arm Immobilization and Long-Arm Immobilization in Conservatively Managed Distal Radius Fractures: A Meta-Analysis and Systematic Review. Cureus. 2024 Mar 8;16(3):e55813. doi: 10.7759/cureus.55813. eCollection 2024 Mar.
- Okamura A, de Moraes VY, Neto JR, Tamaoki MJ, Faloppa F, Belloti JC. No benefit for elbow blocking on conservative treatment of distal radius fractures: A 6-month randomized controlled trial. PLoS One. 2021 Jun 10;16(6):e0252667. doi: 10.1371/journal.pone.0252667. eCollection 2021.
- Caruso G, Tonon F, Gildone A, Andreotti M, Altavilla R, Valentini A, Valpiani G, Massari L. Below-elbow or above-elbow cast for conservative treatment of extra-articular distal radius fractures with dorsal displacement: a prospective randomized trial. J Orthop Surg Res. 2019 Dec 30;14(1):477. doi: 10.1186/s13018-019-1530-1.
- 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.
- Park MJ, Kim JP, Lee HI, Lim TK, Jung HS, Lee JS. Is a short arm cast appropriate for stable distal radius fractures in patients older than 55 years? A randomized prospective multicentre study. J Hand Surg Eur Vol. 2017 Jun;42(5):487-492. doi: 10.1177/1753193417690464. Epub 2017 Mar 1.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 luglio 2020
Completamento primario (Effettivo)
20 giugno 2022
Completamento dello studio (Effettivo)
14 giugno 2026
Date di iscrizione allo studio
Primo inviato
11 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 luglio 2026
Primo Inserito (Effettivo)
15 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2020/882
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
There is no plan to share de-identified individual participant data with other researchers.
No prospective IPD-sharing framework, repository, or data-access process was established for this single-center study.
Participant-level data will therefore not be made available for secondary research; study findings will be reported in aggregate form.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .