Evaluation of pre- and postoperative glenohumeral translation and function (especially exorotation) after open (modified) Bankart procedure versus arthroscopic stabilizing surgery for posttraumatic recurrent shoulder instability.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- glenohumeral range of motion analysis (using the six degree-of-freedom
electromagnetic tracking device *The Flock of Birds tm* (FoB) (Ascension
Technology Inc., Burlington, VT, USA))
- glenohumeral translation measurement (in AP direction)
Secondary outcome
Function measured with Questionaires:
Constant score, Oxford instability score, DASH score, WOSI, Rowe, NSST, a VAS
for pain and a single questioning reflecting satisfaction accompanied with the
quality of life questionnaires (sf-12 and shoulder function assessment score).
Background summary
Dislocation of the glenohumeral joint (mostly in anterior direction) is the
most common dislocation in human joints with a reported incidence of 1% to 2%
in the general population. The prognosis of recurrence after an acute
first-time anterior shoulder dislocation (AFASD) in young patients is reported
to be between 17% and 96%. The best treatment of AFASD in young patients still
remains a debated issue as most published studies have a short follow-up and a
mixed population of patients and pathology.
Both open and arthroscopic repairs are reported successful in the short and
midterm follow-up and both have specific pros and cons.
Open surgery has proven a long term success but may restrict external rotation
and may lead to secondary osteoarthritis. Arthroscopic techniques were
developed in an attempt to avoid the wide dissection with open procedures.
Their claimed advantages include reduced postoperative pain, earlier
rehabilitation and less restriction of movement. Midterm results have however
reported a slightly higher incidence of persistent instability and recurrence
of dislocation.
Until now, mainly cadaver studies regarding the influence of stabilizing
surgery for posttraumatic glenohumeral instability on the glenohumeral
translation and ROM of the shoulder have been performed on various custom
shoulder devices with simulated muscle forces. Clinical studies on GH
translation during abduction and external rotation are scarce and variable.
Study objective
Evaluation of pre- and postoperative glenohumeral translation and function
(especially exorotation) after open (modified) Bankart procedure versus
arthroscopic stabilizing surgery for posttraumatic recurrent shoulder
instability.
Study design
Patients will be enrolled from orthopedic out-patient clinic of the Leiden
University Medical Center, Rijnland hospital, MCH and Reinier de Graaf
Gasthuis, location Delft. All patients with recurrent posttraumatic
glenohumeral instability that fulfil our inclusion criteria will be measured
for Range of Motion (ROM) using a six-degrees-of-freedom tracking device (Flock
of BirdsĀ®). Secondly postoperative glenohumeral postero-anterior translation
during abduction and external rotation using RSA controlled fluoroscopy will be
measured, together with the Range of Motion (ROM) analysis with the Flock of
Birds device.
A total of 20 patients will be tested of which 10 will be treated with the open
modified Bankart procedure followed by a standard Physiotherapy protocol and 10
will be treated using an arthroscopic Bankart technique also followed with a
standard physiotherapy program.
Study burden and risks
Potential risks associated with placement of RSA and normal range of motion
(analysis) of the shoulder joint are negligible. Pain caused by movement in the
normal range of motion of the shoulder is prevented by accurate supervision of
the clinical researcher, during all movement measurements.
Extra effort for patient:
Twice a visit to the Leiden University Medical Centre at the shoulder
laboratory for range of motion analysis translation measurement glenohumeral in
AP direction (once preoperatively and once postoperatively)
reinier de graafweg 3-11
2625 AD Delft
Nederland
reinier de graafweg 3-11
2625 AD Delft
Nederland
Listed location countries
Age
Inclusion criteria
* clinically diagnosed: Posttraumatic glenohumeral instability
* age between 18 and 60 years
* Patients capable and willing of giving informed consent.
Exclusion criteria
* The individual is unable or unwilling to sign the Patient Informed Consent (PIC) specific to this study.
* Patients with an occupation or past-time which is likely to put unusual and extreme strain on the shoulder.
* tumor
* prior surgery
* arthrosis
* Ac pathology
* prednisone use
Design
Recruitment
metc-ldd@lumc.nl
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 | NL32965.098.10 |
Other | volgt |