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

Primary Purpose

Finger Injuries, Finger Fracture, Finger Mallet

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Suture anchor technique
Conservative Treatment
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Finger Injuries focused on measuring Bony mallet injury, Anchor suture, Conservative treatment, DIP joint

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conservative Treatment

Surgical Treatment

Arm Description

Patients were treated with 6 weeks with splinting and were then started on physical therapy for 2 weeks.

Patients were treated with the new suture anchor technique and after 6 weeks were started on physical therapy for 2 weeks.

Outcomes

Primary Outcome Measures

Extension deficit
The inability to actively extend DIP joint to 0 degrees.
DIP flexion
The maximum angle of flexion at DIP joint
Days to return to work
Time to return to work

Secondary Outcome Measures

Full Information

First Posted
July 18, 2017
Last Updated
July 22, 2017
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03228849
Brief Title
Comparison of New Suture Anchor Technique for Bony Mallet Injury Versus Conservative Treatment
Official Title
Conservative Management Equally Effective to New Suture Anchor Technique for Acute Mallet Finger Deformity: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
June 15, 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Finger Injuries, Finger Fracture, Finger Mallet
Keywords
Bony mallet injury, Anchor suture, Conservative treatment, DIP joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly assigned to surgical or conservative groups. After 6 weeks patients in both groups were started on the same rehabilitation protocol.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative Treatment
Arm Type
Active Comparator
Arm Description
Patients were treated with 6 weeks with splinting and were then started on physical therapy for 2 weeks.
Arm Title
Surgical Treatment
Arm Type
Active Comparator
Arm Description
Patients were treated with the new suture anchor technique and after 6 weeks were started on physical therapy for 2 weeks.
Intervention Type
Procedure
Intervention Name(s)
Suture anchor technique
Intervention Description
Suture anchors were used to attach bony fragment. On week 6, patients were then started on physical therapy for 2 weeks.
Intervention Type
Procedure
Intervention Name(s)
Conservative Treatment
Intervention Description
The injured finger was immobilized in an aluminium splint for 6 weeks. Patients were then started on physical therapy for 2 weeks.
Primary Outcome Measure Information:
Title
Extension deficit
Description
The inability to actively extend DIP joint to 0 degrees.
Time Frame
12 months
Title
DIP flexion
Description
The maximum angle of flexion at DIP joint
Time Frame
12 months
Title
Days to return to work
Description
Time 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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sefa Giray Batıbay, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No consent was obtained from the patients specifically to share their participant data.
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Comparison of New Suture Anchor Technique for Bony Mallet Injury Versus Conservative Treatment

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