Cast Immobilization Versus Percutaneous Pinning for Fracture of Radius in an Elderly Patient

NCT ID: NCT06209242

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-12-01

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.

Conditions

Closed Fracture of Lower End of Radius

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cast immobilization

Using cast immobilization with sugar tong and short arm splinting

Group Type: EXPERIMENTAL

Cast immobilization

Intervention Type: PROCEDURE

Using sugar tong slab and then replace to short arm casting within 1 week

Percutaneous pinning

Using k-wire percutaneous pinning

Group Type: EXPERIMENTAL

Percutaneous pinning

Intervention Type: PROCEDURE

Using k- wire percutaneous pinning with local anesthesia with one-day surgery protocol

Interventions

Percutaneous pinning

Using k- wire percutaneous pinning with local anesthesia with one-day surgery protocol

Intervention Type: PROCEDURE

Cast immobilization

Using sugar tong slab and then replace to short arm casting within 1 week

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Savang Vadhana Memorial Hospital, Thailand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teerasit Punprasitwech, MD

Role: PRINCIPAL_INVESTIGATOR

QSMVH

Locations

Queen Savang Vadhana Memorial hospital

Chon Buri, Sriracha, Thailand

Countries

Thailand

Other Identifiers

027/2564

Identifier Type: -

Identifier Source: org_study_id