A Randomized Controlled Trial of the Treatment of Mallet Fractures
1 other identifier
interventional
84
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedAugust 20, 2012
August 1, 2012
2.8 years
October 31, 2010
August 17, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
wound healing disturbances
1 year
Other Outcomes (1)
nail deformaties
1 year
Study Arms (2)
Operative
EXPERIMENTALoperative treatment of a Mallet fracture with a biodegradable Meniscus Arrow®
Conservative
ACTIVE COMPARATORConservative treatment of a Mallet fracture with a Mallet splint
Interventions
Closed reduction of the Mallet fracture and fixation with 1 biodegradable meniscus Arrow®
Conservative treatment of the Mallet fracture with the traditional Mallet splint.
Eligibility Criteria
You may qualify if:
- avulsion fracture involving more than 30% of articular surface
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
st. Elisabeth Hospital
Tilburg, Noord-Barbant, 5022GC, Netherlands
Amphia Hospital
Breda, North Brabant, 4818CK, Netherlands
Catharaina Hospital
Eindhoven, North Brabant, 5623EJ, Netherlands
Twee Steden Hospital
Tilburg, North Brabant, 5042AD, Netherlands
Kennemer Gasthuis Hospital
Haarlem, North Holland, 2035RC, Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, 6532SZ, Netherlands
Related Publications (1)
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.
PMID: 19478891BACKGROUND
Central Study Contacts
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
- Dr. D.B. Wouters
Study Record Dates
First Submitted
October 31, 2010
First Posted
November 2, 2010
Study Start
March 1, 2011
Primary Completion
January 1, 2014
Last Updated
August 20, 2012
Record last verified: 2012-08