Below-Elbow Versus Initial Above-Elbow Casting for Distal Radius Fractures
11. července 2026 aktualizováno: 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
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
93
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Istanbul, Turecko (Türkiye), 34093
- Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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Aktivní komparátor: 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.
|
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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks
Časové okno: 12 weeks after closed reduction
|
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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Raw Isokinetic Peak Torque at Cast Removal
Časové okno: At cast removal, 4 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.
|
At cast removal, 4 weeks after closed reduction
|
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Raw Isokinetic Peak Torque at 12 Weeks
Časové okno: 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.
|
12 weeks after closed reduction
|
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Isokinetic Peak Torque Normalized to Body Weight at Cast Removal
Časové okno: At cast removal, 4 weeks after closed reduction
|
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.
|
At cast removal, 4 weeks after closed reduction
|
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Raw Isokinetic Work per Repetition at Cast Removal
Časové okno: At cast removal, 4 weeks after closed reduction
|
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.
|
At cast removal, 4 weeks after closed reduction
|
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Isokinetic Work per Repetition Normalized to Body Weight at Cast Removal
Časové okno: 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.
|
At cast removal, 4 weeks after closed reduction
|
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Isokinetic Range of Motion at Cast Removal
Časové okno: At cast removal, 4 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.
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At cast removal, 4 weeks after closed reduction
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Affected-to-Unaffected Isokinetic Deficit at Cast Removal
Časové okno: 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
Časové okno: 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
Časové okno: 12 weeks after closed reduction
|
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.
|
12 weeks after closed reduction
|
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Isokinetic Work per Repetition Normalized to Body Weight at 12 Weeks
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 12 weeks after closed reduction
|
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
Časové okno: 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.
|
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
Časové okno: 12 weeks 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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12 weeks after closed reduction
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Number of Participants With Complications or Additional Treatment Through 12 Weeks
Časové okno: 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
Časové okno: 5 years after closed reduction
|
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
Časové okno: 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.
|
5 years after closed reduction
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Treatment Satisfaction Score at 5 Years
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Contralateral Raw Isokinetic Peak Torque at the Initial Injury Assessment
Časové okno: 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.
|
At the initial injury assessment (Day 1)
|
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Contralateral Isokinetic Peak Torque Normalized to Body Weight at the Initial Injury Assessment
Časové okno: At the initial injury assessment (Day 1)
|
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
Časové okno: 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.
|
At the initial injury assessment (Day 1)
|
|
Contralateral Isokinetic Work per Repetition Normalized to Body Weight at the Initial Injury Assessment
Časové okno: 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
Časové okno: 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)
|
|
Contralateral Grip Strength at the Initial Injury Assessment
Časové okno: At the initial injury assessment (Day 1)
|
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.
|
At the initial injury assessment (Day 1)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Alper Ş. Kendirci, M.D., Istanbul University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
2. července 2020
Primární dokončení (Aktuální)
20. června 2022
Dokončení studie (Aktuální)
14. června 2026
Termíny zápisu do studia
První předloženo
11. července 2026
První předloženo, které splnilo kritéria kontroly kvality
11. července 2026
První zveřejněno (Aktuální)
15. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2020/882
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .