Cast Vs Splint in Distal Radius Fractures

NCT05159310 | Unknown

• 1 other identifier: 2019/00510
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate and compare the efficacy of 2 commonly-used methods of fracture immobilisation: (1) Fiberglass cast, and (2) Thermoplastic splint. Both these devices are externally applied and provide pain relief while immobilising the fracture in an acceptable position. Casts and splints are both established devices in routine clinical use.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Splinting results in Quick Disabilities of Arm, Shoulder, Hand (QuickDASH) scores that are not poorer as compared to casting

  The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability. Splinting in patients ≥60 years with distal radius fracture (DRF) results in 12-month QuickDASH scores that are significantly inferior compared to scores in patients treated in cast. The alternate hypothesis is that splinting results in 12-month QuickDASH scores that are not significantly inferior compared to casting in this group of patients.

  12 months

Study Arms (2)

Cast

OTHER

Patients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast. A research assistant will facilitate the randomisation process so that the RC and the treating physician remain blinded to treatment allocation.

Procedure: Cast vs Splint

Splint

OTHER

Patients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast. A research assistant will facilitate the randomisation process so that the RC and the treating physician remain blinded to treatment allocation.

Procedure: Cast vs Splint

Interventions

Cast vs Splint PROCEDURE

Patients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast.

Cast; Splint

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Closed DRF in patients \> 60 years
• Presenting to HRMC within 10 days of injury
• Isolated injury
• With or without M\&R performed in EMD
• Declined surgical fixation after appropriate discussion

You may not qualify if:

• Wounds - skin tears, bad abrasions, open fracture
• Ulnar fracture \> styloid
• Other MSK / non-MSK injuries
• Bilateral fractures
• Prior wrist fractures / wrist surgery
• Other upper limb conditions affecting function (e.g. CVA)
• Cognitive impairment
• Allergy to plaster or fiberglass

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Soumen Das De

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Wan

CONTACT

67728237; vanessa_wan@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study methodology will be a non-inferiority randomized controlled trial (RCT). A non-inferiority design was selected because it is unlikely that splints are superior to casts with regards to the primary outcome - final functional outcome at 12 months. Both intention-to-treat and per-protocol analyses will be performed.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 16, 2021
• Study Start: February 18, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)