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

NCT03228849 | Completed

• 1 other identifier: 2014/288
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Finger Injuries; Finger Fracture; Finger Mallet

Keywords

Bony mallet injury; Anchor suture; Conservative treatment; DIP joint

Outcome Measures

Primary Outcomes (3)

• Extension deficit

  The inability to actively extend DIP joint to 0 degrees.

  12 months

• DIP flexion

  The maximum angle of flexion at DIP joint

  12 months

• Days to return to work

  Time to return to work

  Starting from the date of the start of treatment until patients returns to work, assessed up to 12 months

Study Arms (2)

Conservative Treatment

ACTIVE COMPARATOR

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

Procedure: Conservative Treatment

Surgical Treatment

ACTIVE COMPARATOR

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

Interventions

Suture anchor technique PROCEDURE

Suture anchors were used to attach bony fragment. On week 6, patients were then started on physical therapy for 2 weeks.

Surgical Treatment

Conservative Treatment PROCEDURE

The injured finger was immobilized in an aluminium splint for 6 weeks. Patients were then started on physical therapy for 2 weeks.

Conservative Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Wehbe Schneider type C and type 3 fractures

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (29)

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MeSH Terms

Conditions

Finger Injuries

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Hand Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sefa Giray Batıbay, MD

  Istanbul University

  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: Professor, MD

Model Details: Patients were randomly assigned to surgical or conservative groups. After 6 weeks patients in both groups were started on the same rehabilitation protocol.

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 25, 2017
• Study Start: June 1, 2013
• Primary Completion: June 15, 2015
• Study Completion: July 1, 2015
• Last Updated: July 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)