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A Randomized Controlled Trial of the Treatment of Mallet Fractures

This study is currently recruiting participants.
Verified August 2012 by Conmed Linvatec Benelux
Sponsor:
Information provided by (Responsible Party):
Dr. D.B. Wouters, Conmed Linvatec Benelux
ClinicalTrials.gov Identifier:
NCT01232426
First received: October 31, 2010
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Mallet Fracture
 Procedure: Biodegradable Meniscus Arrow®
Device: Mallet splint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Treatment of Mallet Fractures: Conservative Versus Operative Using One Meniscus Arrow®

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Conmed Linvatec Benelux:

Primary Outcome Measures:
  • Extension deficit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To evaluate the extension deficit after conservative and operative treatment of a Mallet fracture using the Crawford criteria.

  • extension deficit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    at every visit, the extension in the DIP joint, is measured


Secondary Outcome Measures:
  • wound healing disturbances [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    at every control, this is noted


Other Outcome Measures:
  • nail deformaties [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    at every control nail deformaties, if present, are noted


Estimated Enrollment: 84
Study Start Date: March 2011
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232426

Contacts
Contact: D Wouters, MD, PhD +31-134655655 dwouters@tsz.nl
Contact: FLM Aarts, MD +31-639778708 flmaarts@gmail.com

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

Publications:

Responsible Party: Dr. D.B. Wouters, Conmed Linvatec Benelux
ClinicalTrials.gov Identifier: NCT01232426     History of Changes
Other Study ID Numbers: Mallet2010
Study First Received: October 31, 2010
Last Updated: August 17, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013