Objective: The primary objective of this study is to assess the influence of clavicular shortening after fracture consolidation of a midshaft clavicular fracture, on the Active Range of Motion of the arm/shoulder. Measurements are performed with a…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Range of Motion (RoM)
Secondary outcome
• Length of the clavicle: on a conventional X-ray and measured with the
3D-Electromagnetic Motion Tracking Device.
• DASH Outcome Measure
Background summary
Rationale: Fractures of the clavicle are common (2.6-10% of all fractures).
Until recently, (dislocated) midshaft clavicular fractures are considered to
heal with a good prognosis, with few residual symptoms and a low non-union
rate. More recent studies suggest that the percentage of non-union or mal-union
after a dislocated midshaft clavicular fracture is higher than previously
presumed. The influence of different degrees of shortening of the clavicle on
scapular rotation is still unknown. Cadaveric and in vivo studies have revealed
that more than twenty millimetres shortening may cause functional complaints.
However, none of these findings have been objectified by use of Electromagnetic
Motion Tracking devices.
Study objective
Objective: The primary objective of this study is to assess the influence of
clavicular shortening after fracture consolidation of a midshaft clavicular
fracture, on the Active Range of Motion of the arm/shoulder. Measurements are
performed with a 3D-Electromagnetic Motion Tracking Device at one and five
years after the fracture. Secondly, length measurement of the clavicle with the
3D-Electromagnetic Motion Tracking Device is compared to the 2-D X-ray, to
validate accuracy of length measurement with the conventional X-ray.
Study design
Study design: A multiple case series.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Selected patients will participate on a
voluntary base. An X-ray of both shoulders is taken for length measurements of
the clavicles, involving a negligible extra radiation dose. A questionnaire
(DASH-score) on the function of the arm will be filled out. Force of both arms
will be measured with a handheld dynamometer (MicroFET2). The patients will
have to perform movements with both arms, attached to sensors, which will be
recorded with the 3D-Electromagnetic Motion Tracking Device. The study
participants will not gain any personal benefit from this project. The study
may be of value for future patients with a dislocated and shortened midshaft
clavicular fracture however, because in the study results may support decision
making between available treatment options.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
• A (dislocated) midshaft clavicular fracture 1 or 5 years ago.
• Age at time of fracture between 18 and 60 years.
• Clavicular shortening of respectively, <10 mm, 10 - 20 mm and >20 mm.
• Willingness to undergo functional tests with both arms.
Exclusion criteria
• Current or previous fracture in the proximal or distal third of the clavicle, or acromio-clavicular injury.
• Prior surgery to the shoulder or prior shoulder complaints before fracture.
• Neurovascular injury with objectified neurological findings after fracture or developed due to other illnesses.
• Pathologic fracture.
• 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 |
|---|---|
| CCMO | NL37126.058.11 |