Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Below-Elbow Versus Initial Above-Elbow Casting for Distal Radius Fractures

11. juli 2026 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

93

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye), 34093
        • Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Below-Elbow Cast Immobilization
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.
Andre navne:
  • Short-Arm Cast Immobilization
Aktiv komparator: 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.
Procedure: Initial Above-Elbow Cast Followed by Below-Elbow Cast
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.
Andre navne:
  • Initial Long-Arm Cast Followed by Short-Arm Cast

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks
Tidsramme: 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.
12 weeks after closed reduction

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Raw Isokinetic Peak Torque at Cast Removal
Tidsramme: 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
Raw Isokinetic Peak Torque at 12 Weeks
Tidsramme: 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
Isokinetic Peak Torque Normalized to Body Weight at Cast Removal
Tidsramme: 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
Raw Isokinetic Work per Repetition at Cast Removal
Tidsramme: 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
Isokinetic Work per Repetition Normalized to Body Weight at Cast Removal
Tidsramme: 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
Isokinetic Range of Motion at Cast Removal
Tidsramme: 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.
At cast removal, 4 weeks after closed reduction
Affected-to-Unaffected Isokinetic Deficit at Cast Removal
Tidsramme: At cast removal, 4 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.
At cast removal, 4 weeks after closed reduction
Bilateral Grip Strength at Cast Removal
Tidsramme: At cast removal, 4 weeks after closed reduction
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.
At cast removal, 4 weeks after closed reduction
Raw Isokinetic Work per Repetition at 12 Weeks
Tidsramme: 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
Isokinetic Work per Repetition Normalized to Body Weight at 12 Weeks
Tidsramme: 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
Isokinetic Range of Motion at 12 Weeks
Tidsramme: 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
Affected-to-Unaffected Isokinetic Deficit at 12 Weeks
Tidsramme: 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.
12 weeks after closed reduction
Bilateral Grip Strength at 12 Weeks
Tidsramme: 12 weeks after closed reduction
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.
12 weeks after closed reduction
Change in Affected-Hand Grip Strength From 4 to 12 Weeks
Tidsramme: 4 and 12 weeks after closed reduction
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.
4 and 12 weeks after closed reduction
Change in Radial Inclination From Post-Reduction to 12 Weeks
Tidsramme: Immediately after closed reduction and 12 weeks after closed reduction
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.
Immediately after closed reduction and 12 weeks after closed reduction
Change in Radial Height From Post-Reduction to 12 Weeks
Tidsramme: Immediately after closed reduction and 12 weeks after closed reduction
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.
Immediately after closed reduction and 12 weeks after closed reduction
Change in Ulnar Variance From Post-Reduction to 12 Weeks
Tidsramme: Immediately after closed reduction and 12 weeks after closed reduction
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.
Immediately after closed reduction and 12 weeks after closed reduction
Change in Volar Tilt From Post-Reduction to 12 Weeks
Tidsramme: Immediately after closed reduction and 12 weeks after closed reduction
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.
Immediately after closed reduction and 12 weeks after closed reduction
Elbow or Shoulder Pain and Stiffness at Cast Removal
Tidsramme: At cast removal, 4 weeks after closed reduction
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.
At cast removal, 4 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 4 Weeks
Tidsramme: At cast removal, 4 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.
At cast removal, 4 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 12 Weeks
Tidsramme: 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.
12 weeks after closed reduction
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 4 Weeks
Tidsramme: At cast removal, 4 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.
At cast removal, 4 weeks after closed reduction
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 12 Weeks
Tidsramme: 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.
12 weeks after closed reduction
Number of Participants With Complications or Additional Treatment Through 12 Weeks
Tidsramme: From closed reduction through 12 weeks after closed reduction
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.
From closed reduction through 12 weeks after closed reduction
Patient-Rated Wrist and Hand Evaluation Total Score at 5 Years
Tidsramme: 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
Quick Disabilities of the Arm, Shoulder and Hand Total Score at 5 Years
Tidsramme: 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
Treatment Satisfaction Score at 5 Years
Tidsramme: 5 years after closed reduction
Participants rated their satisfaction with the assigned casting treatment on a scale from 0 to 5. Higher scores indicate greater treatment satisfaction.
5 years after closed reduction

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Contralateral Raw Isokinetic Peak Torque at the Initial Injury Assessment
Tidsramme: 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)
Contralateral Isokinetic Peak Torque Normalized to Body Weight at the Initial Injury Assessment
Tidsramme: 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)
Contralateral Raw Isokinetic Work per Repetition at the Initial Injury Assessment
Tidsramme: 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
Tidsramme: 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)
Contralateral Isokinetic Range of Motion at the Initial Injury Assessment
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University

Efterforskere

  • Ledende efterforsker: Alper Ş. Kendirci, M.D., Istanbul University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. juli 2020

Primær færdiggørelse (Faktiske)

20. juni 2022

Studieafslutning (Faktiske)

14. juni 2026

Datoer for studieregistrering

Først indsendt

11. juli 2026

Først indsendt, der opfyldte QC-kriterier

11. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020/882

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Distal Radius Fraktur

Kliniske forsøg med Below-Elbow Cast Immobilization

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Colombia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner