Cast Vs Splint in Distal Radius Fractures

A Randomized Controlled Trial Comparing Clinical Outcomes of Casting Versus Splinting in Distal Radius Fractures in Patients 60 Years and Above

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.

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Cast vs Splint

Detailed Description

Casts and splints are both established methods of treating DRF. Casts have been traditionally the gold standard for non-operative care of fractures, but there are distinct disadvantages such as skin rash and pruritus, malodour, skin maceration and loosening as the initial swelling subsides. Casts require specialized tools for removal and they have to be reapplied by specialized staff if the casts become loose or wet. Splints have the advantage of being removable and therefore facilitate hygiene and provide a better fit because of the adjustable straps. Splints are theoretically less rigid and patient non-compliance because of the ease of removal may result in a greater likelihood of fracture displacement. However, it is known that fractures displace even in casts and the efficacy of casts at maintaining reduction over splints has not been established. Moreover, it has been clearly shown that the elderly patients have good functional outcomes that do not correlate with the position in which the fracture heals i.e. they tolerated a large degree of fracture malunion (Arora; Egol).

The primary goal of this study is to show that there is no difference in the final functional outcome between distal radius fractures treated non-operatively with splints and casts. The secondary goals are to demonstrate: (1) splinting results in greater patient comfort and acceptance; (2) there is no significant difference in final radiographic outcomes between DRF treated with casts and splints; and (3) there is no difference in clinical outcome at the 6-month and 12-month follow-up points.

This study is clinically important for several reasons. First, patients may be encouraged to use splints instead of casts if there is no difference in functional outcome and the former provide better comfort. Second, patients may not be required to present for long (>6-month) follow-ups if it can be shown that the clinical improvement plateaus at 6 months after injury. This is consistent with our aim to improve patients' overall quality of life after musculoskeletal injuries and forms a core component of functional ageing.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Wan; Phone Number: 67728237; Email: vanessa_wan@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Contact: Vanessa Wan; Phone Number: 67728237; Email: vanessa_wan@nuhs.edu.sg
    • Principal Investigator: Soumen Das De

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cast; 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; 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.
Other: Splint; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Investigators: Principal Investigator: Soumen Das De, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 2019/00510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Records for all participants, including all source documentation (containing evidence to study eligibility, history and physical findings, results of consultations etc) as well as IRB records and other regulatory documentation will be retained by the principal investigator via the following means:

• Electronic records will be kept on an encrypted hard drive
• Hardcopy data will be stored in a locked cabinets in the office of the principal investigator and accessed only by the principal investigator, co-investigators or study administrators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No