Comparison of New Suture Anchor Technique for Bony Mallet Injury Versus Conservative Treatment

July 22, 2017 updated by: Hayati Durmaz, Istanbul University

Conservative Management Equally Effective to New Suture Anchor Technique for Acute Mallet Finger Deformity: A Prospective Randomized Clinical Trial

This study aims to compare conservative treatment versus a new suture anchor technique for bony mallet finger in 29 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare conservative treatment versus a new suture anchor technique for bony mallet finger in 29 patients who presented to investigators' clinic between 2013 and 2015. Patients were randomly assigned to conservative or surgical treatment groups. Patients in the conservative group were followed with immobilization with aluminum splint and physical therapy. Patients in the surgical group were treated with investigators' new surgical suture anchor technique and then received physical therapy. The patients were followed for 12 months. Primary study outcomes were extension deficit, days to return to work and DIP flexion.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Wehbe Schneider type 1 - 2 and type A - B fractures
  • ability to provide closed reduction
  • patients' voluntariness

Exclusion Criteria:

  • Wehbe Schneider type C and type 3 fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conservative Treatment
Patients were treated with 6 weeks with splinting and were then started on physical therapy for 2 weeks.
Procedure: Conservative Treatment
The injured finger was immobilized in an aluminium splint for 6 weeks. Patients were then started on physical therapy for 2 weeks.
Active Comparator: Surgical Treatment
Patients were treated with the new suture anchor technique and after 6 weeks were started on physical therapy for 2 weeks.
Procedure: Suture anchor technique
Suture anchors were used to attach bony fragment. On week 6, patients were then started on physical therapy for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extension deficit
Time Frame: 12 months
The inability to actively extend DIP joint to 0 degrees.
12 months
DIP flexion
Time Frame: 12 months
The maximum angle of flexion at DIP joint
12 months
Days to return to work
Time Frame: Starting from the date of the start of treatment until patients returns to work, assessed up to 12 months
Time to return to work
Starting from the date of the start of treatment until patients returns to work, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Sefa Giray Batıbay, MD, Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

June 15, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 22, 2017

First Posted (Actual)

July 25, 2017

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 22, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No consent was obtained from the patients specifically to share their participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Finger Injuries

Clinical Trials on Conservative Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe