The aim of this prospective randomized study is to compare results of plate fixation and intramedullary fixation postoperatively after two weeks and after a follow-up period of one year.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
DASH score 6 months after surgery
Secondary outcome
DASH score after one year
function of the shoulder (Constant Score) 6 months after surgery
DASH and Constant scores at 6 weeks and 3 months
complications, both intra-operatively, immediately postoperatively (two weeks),
and in a period of 1 year after surgery.
the number of re-operations related to unsatisfactory results in a period of
one year after surgery
time to radiological consolidation
perception of pain 2 weeks postoperatively
patient satisfaction with the cosmetic result of the treatment 6 months and one
year after surgery.
elective implant removal in a period of one year after surgery
Addendum: scapulothoracic rythm one year postoperatively (pilot study)
Background summary
Historically clavicular fractures were treated conservatively. Consolidation
was achieved within a few weeks, even with severe dislocation.
However, in the last couple of years poor results (malunion, nonunion and low
patient satisfaction scores) were described of conservatively treated
dislocated midshaft clavicular fractures (DMCF).
The two most commonly used operative techniques for treatment of DMCF are plate
fixation and intramedullary fixation with a Titanium Elastic Nail (TEN). In
recently published prospective randomized studies both techniques proved to be
superior (better functional results and lower nonunion rates) compared to
conservative treatment of DMCF.
However, which technique provides the best results is still unknown. A recent
Cochrane review showed that prospective randomized studies comparing surgical
treatment of DMCF are lacking.
Study objective
The aim of this prospective randomized study is to compare results of plate
fixation and intramedullary fixation postoperatively after two weeks and after
a follow-up period of one year.
Study design
prospective randomized multicenter study
Intervention
plate fixation or intramedullary fixation with a Titanium Elastic Nail (TEN)
Study burden and risks
Risks of surgery for both techniques as described in the protocol.
As previously mentioned both techniques are globally used for surgical
treatment of dislocated midshaft clavicular fractures. Traumasurgeons in the
three participating hospitals have sufficient experience with both techniques.
The extra effort for participating patient will be the completion of the
questionnaires. Treatment and number of outpatient department visits won't be
different.
Addendum: In addition to regular follow up in the outpatient clinic 10
patients, 5 from each group, will be asked to perform standard range of motion
exercises which are to be recorded on video. Further analysis of
scapulothoracic rythm will take place afterwards. This requires approximately
10 minutes of the patients' time without any additional risks for the patients'
health.
Bosboomlaan 1
Utrecht 3582 KE
NL
Bosboomlaan 1
Utrecht 3582 KE
NL
Listed location countries
Age
Inclusion criteria
1) Unilateral dislocated midshaft clavicular fracture
2) No medical contraindications to general anesthesia
3) Provided informed consent
Exclusion criteria
1) Age < 18 years or > 65 years
2) Multitrauma patients
3) Open fracture
4) Pathological fracture
5) Fracture > 1 month old
6) Neurovascular disorders
7) Glasgow Coma Scale <12 (moderate to severe head injury)
8) An inability to comply with follow-up (a transient or an inability to read or complete forms)
9) Pre-existing shoulder pathology in affected side (such as rotator cuff lesion, acromioclavicular pathology or previous shoulder surgery)
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 | NL32928.100.10 |