NCT07704879

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 11, 2026

Last Update Submit

July 11, 2026

Conditions

Keywords

Below-elbow castInitial above-elbow castShort-arm castLong-arm castClosed reductionCast immobilizationNonoperative treatmentIsokinetic dynamometryGrip strengthReduction lossFive-year follow-upWrist fracture

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

EXPERIMENTAL

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

Initial Above-Elbow Cast

ACTIVE COMPARATOR

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

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.

Also known as: Short-Arm Cast Immobilization
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.

Also known as: Initial Long-Arm Cast Followed by Short-Arm Cast
Initial Above-Elbow Cast

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 38590464BACKGROUND
  • 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.

    PMID: 34111160BACKGROUND
  • 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.

    PMID: 31888682BACKGROUND
  • 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.

    PMID: 36189333BACKGROUND
  • 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.

    PMID: 28490225BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Alper Ş. Kendirci, M.D.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After the treating team established that nonoperative treatment was appropriate, participants underwent closed reduction and were randomized in parallel to below-elbow casting or initial above-elbow casting. In the initial above-elbow casting group, the cast was converted to a below-elbow cast at 2 weeks. Cast immobilization ended at 4 weeks in both groups, followed by splinting and rehabilitation.
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.

Locations