Clinical trial NCT05159310: Cast Vs Splint in Distal Radius Fractures
Official title: A Randomized Controlled Trial Comparing Clinical Outcomes of Casting Versus Splinting in Distal Radius Fractures in Patients 60 Years and Above
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Splinting results in Quick Disabilities of Arm, Shoulder, Hand (QuickDASH) scores that are not poorer as compared to casting
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Soumen Das De
role: PRINCIPAL_INVESTIGATOR
References: