Extension Block Pinning vs Conservative Treatment for Mallet Finger Fractures (PO-EBPT)

Pin Orthosis Extension Block Pinning Versus Conservative Treatment for Doyle Type 4B Mallet Fractures

Mallet finger fractures are injuries affecting the tip of the finger and can be treated either with splinting or surgery. However, there is no clear agreement on which treatment provides better outcomes for certain types of these fractures.

In this study, patients with mallet finger fractures were randomly assigned to receive either surgical treatment using a pin-orthosis extension-block pinning technique or conservative treatment with splint immobilization. Patients were followed at regular intervals, and outcomes such as finger movement, function, bone healing, and complications were evaluated over time.

The purpose of this study is to compare these two treatment approaches and determine which one leads to better clinical and functional outcomes.

Study Overview

• Status: Completed
• Conditions: Mallet Finger Fracture
• Intervention / Treatment: Procedure: Pin-Orthosis Extension-Block Pinning Technique; Procedure: Splinting

Detailed Description

Mallet finger fractures, particularly those involving a significant portion of the distal interphalangeal joint articular surface, present a therapeutic challenge, and there is no consensus regarding the optimal treatment strategy. Both conservative management with splinting and various surgical techniques have been described in the literature.

This randomized controlled trial was designed to compare the clinical and radiographic outcomes of the pin-orthosis extension-block pinning technique and conventional conservative treatment in patients with mallet finger fractures. Patients were randomly assigned to either surgical or conservative treatment groups and followed at regular intervals.

Clinical and functional outcomes were assessed throughout the follow-up period to evaluate the effectiveness and safety of both treatment approaches."

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Sultangazi
    • Istanbul, Sultangazi, Turkey (Türkiye), 34265
      • Haseki Training and Research Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age between 18 and 65 years
• Acute mallet fracture (≤ 3 weeks from injury)
• Fracture fragment involving 20-50% of the distal interphalangeal (DIP) joint articular surface

Exclusion Criteria:

• Open fractures
• Chronic mallet fractures (> 3 weeks from injury)
• Fracture fragment involving more than 50% of the DIP joint articular surface
• Open physes
• Inability to complete 12-month follow-up

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
Experimental: Surgical Treatment (PO-EBPT); Participants in this group underwent surgical treatment using the pin-orthosis extension-block pinning technique.	Procedure: Pin-Orthosis Extension-Block Pinning Technique; The pin-orthosis extension-block pinning technique was performed under appropriate anesthesia. A Kirschner wire was used to block extension at the distal interphalangeal joint and stabilize the fracture fragment, followed by immobilization with an orthosis. The fixation was maintained for a defined period, and patients were followed according to the study protocol.
Active Comparator: Conservative Treatment (Splinting); Participants in this group received conservative treatment with splint immobilization of the distal interphalangeal joint.	Procedure: Splinting; Conservative treatment consisted of continuous splint immobilization of the distal interphalangeal joint in extension. Patients were instructed to maintain uninterrupted splint use for the recommended duration with regular follow-up visits to monitor compliance and clinical progress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distal Interphalangeal Joint Extension Lag	Degree of extension lag at the distal interphalangeal joint measured using a goniometer.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distal Interphalangeal Joint Range of Motion	Range of motion of the distal interphalangeal joint measured in degrees.	Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
Functional Outcome According to Crawford Criteria	Functional outcome assessed using the Crawford classification system.	12 months
Fracture Union	Radiographic evidence of fracture healing assessed during follow-up.	Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
Complication Rate	Incidence of treatment-related complications observed during the study period.	Up to 12 months

Collaborators and Investigators

• Sponsor: Haseki Training and Research Hospital
• Investigators: Principal Investigator: Kemal A Col, Doctor, Haseki Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Conservative treatment; crawford criteria; extension-block pinning technique; mallet fracture; pin orthosis
• Additional Relevant MeSH Terms: External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Splints
• Other Study ID Numbers: 39-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy and institutional data protection policies.

Drug and device information, study documents

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