Extension Pin Block vs Pin Orthosis-extension Block Pinning for Bonny Mallet Fractures

NCT05857683 | Unknown

• 1 other identifier: AnkaraUniHand
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center prospective study comparing the extension pin block vs pin orthosis-extension block pinning for bonny mallet fractures.

Conditions

Mallet Finger

Outcome Measures

Primary Outcomes (5)

• Crawford criteria

  functional scoring for the DIP joint, focuses on range of motion and pain

  postoperative 1st day

• Crawford criteria

  functional scoring for the DIP joint, focuses on range of motion and pain

  postoperative 1st month

• Crawford criteria

  functional scoring for the DIP joint, focuses on range of motion and pain

  postoperative 3rd month

• Crawford criteria

  functional scoring for the DIP joint, focuses on range of motion and pain

  postoperative 6th month

• Crawford criteria

  functional scoring for the DIP joint, focuses on range of motion and pain

  postoperative 12th month

Secondary Outcomes (5)

• complications

  postoperative 1st day

• complications

  postoperative 1st month

• complications

  postoperative 3rd month

• complications

  postoperative 6th month

• complications

  postoperative 12th month

Study Arms (2)

extension pin block

ACTIVE COMPARATOR

this is the technique for mallet finger where 2 pins are used, one for the extension block and other intramedullary for the extension posture

Procedure: cextension pin block

pin orthosis- extension block pin

ACTIVE COMPARATOR

this is the technique for mallet finger where only 1 pin is used for extension block and an orthosis is applied for the extension posture

Procedure: pin orthosis- extension block pin

Interventions

cextension pin block PROCEDURE

this is the technique for mallet finger where 2 pins are used, one for the extension block and other intramedullary for the extension posture

extension pin block

pin orthosis- extension block pin PROCEDURE

this is the technique for mallet finger where only 1 pin is used for extension block and an orthosis is applied for the extension posture

pin orthosis- extension block pin

Eligibility Criteria

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

You may qualify if:

• years and older patients
• Wehbe classification type 2 b (Type Definition) I No DIP joint subluxation II DIP joint subluxation III Epiphyseal and physeal injuries Subtype A Avulsed fragment \<1/3 of articular surface B Avulsed fragment 1/3-2/3 of articular surface C Avulsed fragment \>2/3 of articular surface )
• Isolated bonny mallet fractures
• Minimum 1 year follow up
• Good cognitive status

You may not qualify if:

• Patients under the age of 18
• Open fracture
• Chronic mallet finger
• TFracture area that includes more than 50% of the joint face
• Patients whose follow-up less than 1 year

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Medical Faculty

Ankara, 06680, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Malik Kısmet, MD

CONTACT

00905063436401; malikkismett@gmail.com

Yener Yoğun, MD

CONTACT

00905364310071; yeneryogunluk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: June 2024

Locations

TU (1)