Below-Elbow Versus Initial Above-Elbow Casting for Distal Radius Fractures
1 other identifier
interventional
93
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2026
CompletedFirst Submitted
Initial submission to the registry
July 11, 2026
CompletedFirst Posted
Study publicly available on registry
July 15, 2026
CompletedJuly 15, 2026
July 1, 2026
2 years
July 11, 2026
July 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks
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
Secondary Outcomes (27)
Raw Isokinetic Peak Torque at Cast Removal
At cast removal, 4 weeks after closed reduction
Raw Isokinetic Peak Torque at 12 Weeks
12 weeks after closed reduction
Isokinetic Peak Torque Normalized to Body Weight at Cast Removal
At cast removal, 4 weeks after closed reduction
Raw Isokinetic Work per Repetition at Cast Removal
At cast removal, 4 weeks after closed reduction
Isokinetic Work per Repetition Normalized to Body Weight at Cast Removal
At cast removal, 4 weeks after closed reduction
- +22 more secondary outcomes
Other Outcomes (6)
Contralateral Raw Isokinetic Peak Torque at the Initial Injury Assessment
At the initial injury assessment (Day 1)
Contralateral Isokinetic Peak Torque Normalized to Body Weight at the Initial Injury Assessment
At the initial injury assessment (Day 1)
Contralateral Raw Isokinetic Work per Repetition at the Initial Injury Assessment
At the initial injury assessment (Day 1)
- +3 more other outcomes
Study Arms (2)
Below-Elbow Cast
EXPERIMENTALAfter 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.
Initial Above-Elbow Cast
ACTIVE COMPARATORAfter 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
Istanbul, 34093, Turkey (Türkiye)
Related Publications (5)
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.
PMID: 38590464BACKGROUNDOkamura 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.
PMID: 34111160BACKGROUNDCaruso 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.
PMID: 31888682BACKGROUNDDib 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.
PMID: 36189333BACKGROUNDPark 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.
PMID: 28490225BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alper Ş. Kendirci, M.D.
Istanbul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Orthopaedics and Traumatology
Study Record Dates
First Submitted
July 11, 2026
First Posted
July 15, 2026
Study Start
July 2, 2020
Primary Completion
June 20, 2022
Study Completion
June 14, 2026
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.