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

Mallet Finger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857683
• Other study ID #: AnkaraUniHand
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: Ankara University
• Contact: Malik Kismet, MD
• Phone: 00905063436401
• Email: malikkismett[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mallet Finger

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Ankara University Medical Faculty	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crawford criteria	functional scoring for the DIP joint, focuses on range of motion and pain	postoperative 1st day
Primary	Crawford criteria	functional scoring for the DIP joint, focuses on range of motion and pain	postoperative 1st month
Primary	Crawford criteria	functional scoring for the DIP joint, focuses on range of motion and pain	postoperative 3rd month
Primary	Crawford criteria	functional scoring for the DIP joint, focuses on range of motion and pain	postoperative 6th month
Primary	Crawford criteria	functional scoring for the DIP joint, focuses on range of motion and pain	postoperative 12th month
Secondary	complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 1st day
Secondary	complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 1st month
Secondary	complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 3rd month
Secondary	complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 6th month
Secondary	complications	skin necrosis, loss of range of motion, infection, nail bed injury	postoperative 12th month