Cast Immobilization Versus Percutaneous Pinning for Fract... | NCT06209242

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

NCT06209242

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Status

Completed

Last Update Posted

Jan 17, 2024Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Closed Fracture of Lower End of Radius

Interventions

Percutaneous pinning
Cast immobilization

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

Dec 20, 2023

First Submission Date that Met QC Criteria

Jan 7, 2024

First Posted Date

Jan 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2024

Last Update Posted Date

Jan 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cast immobilization	Experimental	Using cast immobilization with sugar tong and short arm splinting	Procedure: Cast immobilization
Percutaneous pinning	Experimental	Using k-wire percutaneous pinning	Procedure: Percutaneous pinning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous pinning	Procedure	Using k- wire percutaneous pinning with local anesthesia with one-day surgery protocol	Percutaneous pinning

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Teerasit Punprasitwech, MD	QSMVH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Savang Vadhana Memorial hospital		Chon Buri	Sriracha	20110	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Data was save inform of excel, sheets and SPSS

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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.