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

NCT06209242 | Completed DMC

• 1 other identifier: 027/2564
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Closed Fracture of Lower End of Radius

Outcome Measures

Primary Outcomes (1)

• Radiological parameters

  Radial angulation, radial inclination, ulnar deviation, radial height

  1 wk , 4 wk , 3 months

Secondary Outcomes (2)

• DASH score

  1 month, 3 months

• Hand function

  1 month, 3 months

Study Arms (2)

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

Percutaneous pinning PROCEDURE

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

Percutaneous pinning

Cast immobilization PROCEDURE

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

Cast immobilization

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Vadhana Memorial hospital

Chon Buri, Sriracha, 20110, Thailand

Location

Study Officials

• Teerasit Punprasitwech, MD

  QSMVH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 17, 2024
• Study Start: August 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)