Cast Vs Splint in Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05159310
• Other study ID #: 2019/00510
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: National University Hospital, Singapore
• Contact: Vanessa Wan
• Phone: 67728237
• Email: vanessa_wan[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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