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

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

Study Overview

• Status: Recruiting
• Conditions: Mallet Finger
• Intervention / Treatment: Procedure: cextension pin block; Procedure: pin orthosis- extension block pin

Detailed Description

Mallet finger is a fracture of the distal phalanx involving the dorsal articular surface. It is important because it concerns the extensor tendon attachment site. The clinical manifestation of mallet finger formation is active extension loss at the DIP joint. If the injury is not treated and becomes chronic, the DIP passive extension is gradually lost and a hyperextension posture occurs in the PIP joint due to the compensatory swan neck deformity. Non-surgical methods have an important place in the treatment of mallet finger injuries. The indications for surgical treatment of mallet finger injuries are a matter of debate. Conditions that are widely accepted as definite surgical indications are open injury, individuals who cannot work with a splint, the ruptured dorsal part is large and includes more than 30% of the articular surface, and the presence of palmar subluxation in the DIP. Among the mallet finger surgical treatments, the extension pin block technique , bracing in extension, hook method are defined.

In this prospective study, we aimed to compare the extension pin block technique with the pin orthosis-extension block pinning. In comparison, the patients eligible for the study will be evaluated according to Crawford criteria for function evaluation, complications (infection, nail deformities, skin necrosis, DIP joint osteoarthritis), recovery time.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malik Kısmet, MD; Phone Number: 00905063436401; Email: malikkismett@gmail.com
• Study Contact Backup: Name: Yener Yoğun, MD; Phone Number: 00905364310071; Email: yeneryogunluk@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06680
    • Recruiting
    • Ankara University Medical Faculty
    • Contact: Malik Kısmet; Phone Number: 005063436401; Email: malikkismett@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: extension pin block; 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; this is the technique for mallet finger where 2 pins are used, one for the extension block and other intramedullary for the extension posture
Active Comparator: pin orthosis- extension block pin; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 1st day
complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 1st month
complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 3rd month
complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 6th month
complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 12th month

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AnkaraUniHand

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Collected data will be shared after reaching the minimum required number and performing the analysis
• IPD Sharing Time Frame: June 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No