The aim is to study the long-term functional and radiological results (i.e. cuff integrity) of arcromioplasty in patients with SIS after a 8-13 year follow-up period.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
De primary clinical outcome is the Constant Murley Score and the primary
radiological outcome is the presence of a partial or full-thickness rotator
cuff tear on MR-arthrography.
Secondary outcome
Clinical evaluation (measured by validated questionnaires)
Simple Shoulder Test
Visual Analogue Scale ( VAS) for pijn during shoulder movement and in rest
Western Ontario Rotator Cuff Index (Disease specific quality of life)
Anchor questions on treatment outcome evaluation on a Likert Scale
Radiological evaluation:
Occupation ratio en cross-sectional surface area
Fatty degeneration measured by using the Goutallier classificatie
Acromial shape (Bigliani)
Acromiohumoral cranialisation (AH distance)
Type and extend of the rotator cuff tear
Background summary
The subacromial impingement syndrome has a high incidence in patients aged
40-60 years and has a major impact on daily life and job-specific activities.
When complaints of shoulder pain persists after conservative treatment
approaches are unsuccesful, the acromioplasty is performed. Nevertheless, the
results of the acromioplasty are highly variable and it is unclear if damage to
subacromial structures is prevented by an acromioplasty. Clinical results do
not depent on the type of surgical procedure (acromioplasty in combination with
bursectomy or bursectomy) after a short-term follow-up. However long-term
follow-up is needed as rotator cuff degenerate with time and consequences of
extrinsic compression migh be only seen with long-term follow-up. We
hypothesise that long-term clinical and radiologic results are comparable
between acromioplasty in combination with a bursectomy and bursectomy.
Therefore the aim is to study the long-term functional and radiological results
(i.e. cuff integrity) of arcromioplasty in patients with SIS after a 8-13 year
follow-up period.
Study objective
The aim is to study the long-term functional and radiological results (i.e.
cuff integrity) of arcromioplasty in patients with SIS after a 8-13 year
follow-up period.
Study design
Follow-up study of a randomized controlled study cohort with a 8-13 jaar
follow-up period.
Study burden and risks
Patients are requested to complete validated shoulder questionnaires to assess
shoulder function and shoulder specific quality of life (15 min). Furthermore
patients are invited for an clinical evaluation at the outpatient clinic (15
min). Afterwards patients will be investiged by a MR arthrography in order to
study radiologic parameters and especially the presence of a rotator cuff
tear(30min). The estimated total time is 60 min.
Intra-artricular contrast used in MR arthrography has limited (<0.1%)
complication risks. These risks include septic arthritis, cellulitis and an
allergic reaction.
Lijnbaan 32 Lijnbaan 32
Den Haag 2501 CK
NL
Lijnbaan 32 Lijnbaan 32
Den Haag 2501 CK
NL
Listed location countries
Age
Inclusion criteria
Patients were previously included according to the inclusion and exclusion criteria used in the conducted randomized controlled trial by Henkus et al, JBJS [BR], 2009. ;The previous inclusion criteria were:
Nontraumatic pain in the deltoid region
Inability to lie on the affected side.
Pain provocation by abduction and retroversion or internal rotation.
Positive Neer test
Positive Hawkins test
positive lidocaine impingement test;Exclusion criteria:
Limitiations in passive range of motion.
Glenohumeral instability
Any form of arthritis in the glenohumeral or acromioclavicular joint
Biceps tendinitis
Rotator cuff tear
Cervical radiolopathy
Calcifying tendonitis;All previous included patients are included in the current trial.
Exclusion criteria
Only patients who suffered from a fracture/trauma are excluded in the current trial
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 | NL49198.098.14 |