COnservative Treatment of MEtacarpal fractures with a Plasteraid Splint;(acronym COTMEPS)

Completed

Conditions: hand fracture
metacarpal fracture
10017322

Registration Number: NL-OMON32190

Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Patients with closed fractures of the metacarpal II-V (including boxer's fracture) that are not older than 72 hours, with or without the need for fracture reduction. Patients have to be older than 18 years old and without ipsilateral or associated injury (i.e. more fractures of the same hand).

Exclusion Criteria

Open or pathological fractures, ipsilateral hand fractures, severe rotation deformity or ulnar/radial angulation, severe bone shortening, associated injury and the probability of loss to follow-up. A primary indication for operation according to local hospital customs and/or protocols is an exclusion criteria. Language barriers and/or intoxication which can*t guarantee adequate follow-up or understanding of the study and/or informed consent.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the DASH-DLV (Disabilities of the Arm, Shoulder and<br /><br>Hand-Dutch Language Version), a validated Dutch translation (Veehof 2002) of<br /><br>the original DASH (Beaton 2001) to evaluate disabilities and symptoms as a<br /><br>result of the metacarpal fracture treatment and to evaluate the ability of the<br /><br>Plasteraid splint to hold the desired 90-0-0 position. This DASH-DLV scoring<br /><br>form is filled out by the patients at t=0,1,4 and 8 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following items will be secondary parameters/endpoints:<br /><br>Full active range of motion (ROM) of the MCP joint 8 weeks following removal of<br /><br>the splint.<br /><br>The need for physiotherapy and time to return to hobby or profession (at t=8<br /><br>weeks) and loss to follow-up. </p><br>