No registrations found.
ID
Source
Brief title
Health condition
clavicle, shortening, functional outcome, 3D-Electromagnetic Motion Tracking Device,
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the influence of clavicular shortening after fracture consolidatin of a midshaft clavicular fracture, on the Active Range of Motion of the shoulder, with help of a 3D-Electromagnetic Motion Tracking Device (Flock of Birds) after one and five years post-fracture.
Secondary outcome
The secondary objective will be to compare the clavicular length as measured on a conventional X-ray as usual care and estimated with the 3D-Electromagnetic Motion Tracking Device on the basis of the bony landmarks. Furthermore,force measurements of both arms will be accomplished with use of MicroFETs, a handheld dynamometer. Each participants is asked to fill out a questionnaire related to the function of arm, shoulder and Hand (Disabilities of Arm, Shoulder and Hand-Outcome Measure (DASH)).
Background summary
N/A
Study objective
From the literature it i likely that shortening of the clavicule >15mm leads to impairment of the shoulder function (especially regarding abduction). This association has not been scientifically proven, howeer, partially due to the fact that methods for a precise measurement of functional impairment of the shoulder are lacking. In this pilot study we want to study whether a new technique, 3D-Electromagnetic Motion Tracking Device (Flock of Birds), can provide more insight into this association. We assume that at most 10% of the patients with clavicular shortening <15 mm experience impairment in abduction. On anatomical grounds we expect that this percentage is at least 50% in the patients with a clavicular shortening> 15 mm.
Study design
N/A
Intervention
N/A
Inclusion criteria
1. A (dislocated) midshaft clavicular fracture 1 or 5 years ago;
2. Age when fracture occured above 18 and below 60 years;
3. Clavicular shortening of respectively, <10mm, 10-20mm and >20 mm.
Exclusion criteria
1. Current or previous fracture in the proximal or distal third of the clavicule, or acromio-clavicular injury;
2. Prior surgery to the shoulder or prior shoulder complaints before fracture;
3. Neurovascular injury with objective neurological findings after fracture or developed due to other illnesses;
4. Pathologic fracture;
5. New fractures of ipsilateral or contralateral shoulders/arm that could influence the active Range of Motion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3019 |
| NTR-old | NTR3167 |
| Other | METC LUMC : P11.101 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |