A Randomized Controlled Trial of the Treatment of Mallet Fractures

A Randomized Controlled Trial of the Treatment of Mallet Fractures: Conservative Versus Operative Using One Meniscus Arrow®

Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually referred to as Mallet fractures. Treatment of Mallet fractures remains controversial. Although no differences in clinical results are reported between conservative treatment and operative treatment, operative treatment is suggested for fractures involving more than 30% of articular surface. There are many different operative techniques, all with specific disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet splint.

Study Overview

• Status: Unknown
• Conditions: Mallet Fracture
• Intervention / Treatment: Procedure: Biodegradable Meniscus Arrow®; Device: Mallet splint

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: D Wouters, MD, PhD; Phone Number: +31-134655655; Email: dwouters@tsz.nl
• Study Contact Backup: Name: FLM Aarts, MD; Phone Number: +31-639778708; Email: flmaarts@gmail.com

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6532SZ
    • Not yet recruiting
    • Canisius-Wilhelmina Hospital
    • Contact: W vd Stappen, MD
  • Noord-Barbant
    • Tilburg, Noord-Barbant, Netherlands, 5022GC
      • Recruiting
      • St. Elisabeth Hospital
      • Contact: M. Verhofstad, MD,PhD
      • Principal Investigator: M Verhofstad, MD, PhD
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands, 4818CK
      • Not yet recruiting
      • Amphia Hospital
      • Contact: D de Vos, MD, PhD
    • Eindhoven, Noord-Brabant, Netherlands, 5623EJ
      • Not yet recruiting
      • Catharaina Hospital
      • Contact: A vdVeen, Md, PhD
    • Tilburg, Noord-Brabant, Netherlands, 5042AD
      • Recruiting
      • Twee Steden Hospital
      • Principal Investigator: Fenne Aarts, MD
  • Noord-Holland
    • Haarlem, Noord-Holland, Netherlands, 2035RC
      • Not yet recruiting
      • Kennemer Gasthuis Hospital
      • Contact: M Heetveld, Md, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• avulsion fracture involving more than 30% of articular surface

Exclusion Criteria:

• (sub)luxation of the distal phalanx
• patients with a Mallet fracture developed 3 weeks or more prior to presentation
• patients with a Mallet fracture with failure of conservative treatment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Operative; operative treatment of a Mallet fracture with a biodegradable Meniscus Arrow®	Procedure: Biodegradable Meniscus Arrow®; Closed reduction of the Mallet fracture and fixation with 1 biodegradable meniscus Arrow®
Active Comparator: Conservative; Conservative treatment of a Mallet fracture with a Mallet splint	Device: Mallet splint; Conservative treatment of the Mallet fracture with the traditional Mallet splint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension deficit	To evaluate the extension deficit after conservative and operative treatment of a Mallet fracture using the Crawford criteria.	1 year
extension deficit	at every visit, the extension in the DIP joint, is measured	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing disturbances	at every control, this is noted	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
nail deformaties	at every control nail deformaties, if present, are noted	1 year

Collaborators and Investigators

• Sponsor: Conmed Linvatec Benelux

Publications and helpful links

General Publications

• Nelis R, Wouters DB. Is the use of biodegradable devices in the operative treatment of avulsion fractures of fingers, the so-called mallet finger advantageous? A feasibility study with meniscus arrows. Open Orthop J. 2008 Nov 3;2:151-4. doi: 10.2174/1874325000802010151.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: October 31, 2010
• First Submitted That Met QC Criteria: November 1, 2010
• First Posted (Estimate): November 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 20, 2012
• Last Update Submitted That Met QC Criteria: August 17, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Mallet2010