The purpose of this study is to assess the long-term outcome after conservative therapy for Rockwood type I-II acromioclavicular injuries with regard to subjective and objective functional outcome.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the functional outcome of the injured shoulder
compared to the contralateral shoulder, measured by two patient-reported
outcome measures; the DASH and the Nottingham Clavicle Score. In a subgroup of
80 patients two functional outcome scores will be measured; the Constant score
and the ASES.
Secondary outcome
AC pressure pain and the cross arm adduction test Range of motion Radiographic
displacement Radiographic joint space Radiographic changes: (degenerative
changes, ossification of the ligaments, distal clavicular osteolysis) The need
for subsequent surgery due to chronic AC-pathology Patient satisfaction Return
to sports
Background summary
Rockwood I-II acromioclavicular joint injuries are generally treated
conservatively. Not much literature exists on the long-term outcome, however
few studies have shown higher rates of chronic acromioclavicular joint
pathology than previously recognized. Patients risk being inadequately informed
on possible residual symptoms or the need for subsequent surgery.
Study objective
The purpose of this study is to assess the long-term outcome after conservative
therapy for Rockwood type I-II acromioclavicular injuries with regard to
subjective and objective functional outcome.
Study design
This study will be a case series based on retrospective data collection and
prospectively measured self-reported outcomes and. A subset of 80 patients will
be radiologically and clinically evaluated for current outcomes.
Study burden and risks
All patients will be asked to fill in a digital a questionnaire. The
questionnaires will take about 15-30 minutes to complete. 80 patients will be
invited for a visit to OLVG for clinical and radiological follow-up. The burden
and risk associated with returning to the OLVG for physical examination can be
considered low. The risk associated with the making of two radiographs of the
shoulder is an exposure of radiation approximately 6 uSv. This amount of
radiation is comparable to the radiation exposure the average inhabitant of the
Netherlands receives during a day (7uSv) and therefore is regarded a negligible
risk. The follow-up activities will be completed in 1.5 hours, including the
radiographs.
Jan tooropstraat 164
Amsterdam 1061AE
NL
Jan tooropstraat 164
Amsterdam 1061AE
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, patients have to meet all of the following criteria: - currently 18 years or older, - diagnosed with a Rockwood type I-II acromioclavicular injury, - a minimal follow-up of 2 years after AC-injury, - antero-posterior radiographs at the time of presentation, - able to read and write in the Dutch language in order to complete the questionnaires and to sign informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: - previous shoulder injuries (fractures, rotator cuff injuries, shoulder instability) or previous surgery in either the injured or contralateral shoulder at the time of presentation. - additional shoulder injuries (fractures, rotator cuff injuries, shoulder instability) or surgery in either the injured or contralateral shoulder at the time of presentation. - unable to sign informed consent or complete the questionnaires for other reasons than illiteracy in Dutch.
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 | NL67035.100.18 |