Clinical trial NCT06209242: Cast Immobilization Versus Percutaneous Pinning for Fracture of Radius in an Elderly Patient
Official title: Cast Immobilization Versus Percutaneous Pinning in Local Anesthesia for Extra-articular Fracture of Distal End Radius in an Elderly Patient: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Fracture of Lower End of Radius
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This prospective randomized controlled trial enrolled participants aged over 60 years with AO23-A2 or AO23-A3 distal radius fractures and no contraindications for local anesthesia. The participants were randomly assigned to either the cast immobilization or percutaneous pinning group.
Primary purpose: TREATMENT

Brief summary: Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.

Detailed description: Background: Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.

Methods: This prospective randomized controlled trial enrolled participants aged over 60 years with AO23-A2 or AO23-A3 distal radius fractures and no contraindications for local anesthesia. The participants were randomly assigned to either the cast immobilization or percutaneous pinning group. Follow-up was conducted for 3 months, during which radiological outcomes and clinical outcomes were assessed. Radiological parameters included radial angulation, while clinical outcomes were evaluated using the Disability of Arm, Shoulder, and Hand (DASH) score, range of motion, and grip strength. Additionally, data on complications and pain levels measured using the Visual Analog Scale (VAS) were collected for the percutaneous pinning group under local anesthesia.

Eligibility criteria: Inclusion Criteria:

* aged \>60 years
* primary distal end radius fracture type AO23-A2 or AO23-A3

Exclusion Criteria:

* multiple trauma
* onset \> 2 weeks
* systemic diseases such as RA
* steroid user
* contraindication for LA

Primary outcomes:
measure: Radiological parameters
timeFrame: 1 wk , 4 wk , 3 months
Secondary outcomes:
measure: DASH score
timeFrame: 1 month, 3 months
measure: Hand function
timeFrame: 1 month, 3 months
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Queen Savang Vadhana Memorial hospital
state: Sriracha
Study officials:
affiliation: QSMVH
name: Teerasit Punprasitwech, MD
role: PRINCIPAL_INVESTIGATOR
References: