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OpenTrials
Completed

NCT Number: NCT07560137

Extension Block Pinning vs Conservative Treatment for Mallet Finger 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.

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Key information

Conditions

Mallet Finger Fracture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Distal Interphalangeal Joint Extension Lag

    Time frame: 12 months

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

Secondary outcomes

  1. Distal Interphalangeal Joint Range of Motion

    Time frame: Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)

    Range of motion of the distal interphalangeal joint measured in degrees.

  2. Functional Outcome According to Crawford Criteria

    Time frame: 12 months

    Functional outcome assessed using the Crawford classification system.

  3. Fracture Union

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

    Radiographic evidence of fracture healing assessed during follow-up.

  4. Complication Rate

    Time frame: Up to 12 months

    Incidence of treatment-related complications observed during the study period.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: PO-EBPT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.