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

January 7, 2024 updated by: Queen Savang Vadhana Memorial Hospital, Thailand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Sriracha
      • Chon Buri, Sriracha, Thailand, 20110
        • Queen Savang Vadhana Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cast immobilization
Using cast immobilization with sugar tong and short arm splinting
Procedure: Cast immobilization
Using sugar tong slab and then replace to short arm casting within 1 week
Experimental: Percutaneous pinning
Using k-wire percutaneous pinning
Procedure: Percutaneous pinning
Using k- wire percutaneous pinning with local anesthesia with one-day surgery protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological parameters
Time Frame: 1 wk , 4 wk , 3 months
Radial angulation, radial inclination, ulnar deviation, radial height
1 wk , 4 wk , 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH score
Time Frame: 1 month, 3 months
Functional outcome
1 month, 3 months
Hand function
Time Frame: 1 month, 3 months
Range of motion, grip strength
1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Investigators

  • Principal Investigator: Teerasit Punprasitwech, MD, QSMVH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

January 7, 2024

First Posted (Estimated)

January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 027/2564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data was save inform of excel, sheets and SPSS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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