Extension Block Pinning vs Conservative Treatment for Mallet Finger Fractures

NCT07560137 | Completed

• 1 other identifier: 39-2022
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mallet Finger Fracture

Keywords

Conservative treatment; crawford criteria; extension-block pinning technique; mallet fracture; pin orthosis

Outcome Measures

Primary Outcomes (1)

• Distal Interphalangeal Joint Extension Lag

  Degree of extension lag at the distal interphalangeal joint measured using a goniometer.

  12 months

Secondary Outcomes (4)

• Distal Interphalangeal Joint Range of Motion

  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

  12 months

• Fracture Union

  Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)

• Complication Rate

  Up to 12 months

Study Arms (2)

Surgical Treatment (PO-EBPT)

EXPERIMENTAL

Participants in this group underwent surgical treatment using the pin-orthosis extension-block pinning technique.

Procedure: Pin-Orthosis Extension-Block Pinning Technique

Conservative Treatment (Splinting)

ACTIVE COMPARATOR

Participants in this group received conservative treatment with splint immobilization of the distal interphalangeal joint.

Procedure: Splinting

Interventions

Pin-Orthosis Extension-Block Pinning Technique PROCEDURE

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.

Surgical Treatment (PO-EBPT)

Splinting PROCEDURE

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.

Conservative Treatment (Splinting)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Kemal A Col, Doctor

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

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: Orthopaedic Surgeon

Model Details: Participants were randomly assigned to one of two parallel groups: surgical treatment using the pin-orthosis extension-block pinning technique or conservative treatment with splinting. Each participant remained in the assigned group throughout the study

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: January 13, 2022
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)