Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative | Experimental | operative treatment of a Mallet fracture with a biodegradable Meniscus Arrow® |
|
| Conservative | Active Comparator | Conservative treatment of a Mallet fracture with a Mallet splint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodegradable Meniscus Arrow® | Procedure | Closed reduction of the Mallet fracture and fixation with 1 biodegradable meniscus Arrow® |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| wound healing disturbances | at every control, this is noted | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| nail deformaties | at every control nail deformaties, if present, are noted | 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| D Wouters, MD, PhD | Contact | +31-134655655 | dwouters@tsz.nl | |
| FLM Aarts, MD | Contact | +31-639778708 | flmaarts@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| st. Elisabeth Hospital | Recruiting | Tilburg | Noord-Barbant | 5022GC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19478891 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mallet splint | Device | Conservative treatment of the Mallet fracture with the traditional Mallet splint. |
|
| Amphia Hospital | Not yet recruiting | Breda | North Brabant | 4818CK | Netherlands |
|
| Catharaina Hospital | Not yet recruiting | Eindhoven | North Brabant | 5623EJ | Netherlands |
|
| Twee Steden Hospital | Recruiting | Tilburg | North Brabant | 5042AD | Netherlands |
|
| Kennemer Gasthuis Hospital | Not yet recruiting | Haarlem | North Holland | 2035RC | Netherlands |
|
| Canisius-Wilhelmina Hospital | Not yet recruiting | Nijmegen | 6532SZ | Netherlands |
|