1. To assess the correlation between the use of bioabsorbable anchors and the early postoperative rate of shoulder stiffness in comparison to the use of non-absorbable titanium and synthetic (PEEK) anchors in arthroscopic rotator cuff repair.2. To…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference between the three, previous described patient groups, with
regard to: postoperative shoulder stiffness (ea. a 10* deficit in postoperative
external rotation).
Secondary outcome
Postoperative outcome: functional (according to Oxford Shoulder Score and Range
Of Motion), Tendon integrity (ultra sound).Postoperative pain (VAS). Patient
satisfaction (very satisfied, satisfied, not satisfied, displeased). Total
number of adverse reactions. Also record any side effects encountered.
Cost-effectiveness of the three different types of anchors used.
Background summary
Rationale: Rotator cuff lesions are not rare and can lead to unexplained pain
and considerable disability, incidence varying between 10 to 35 %. Good to
excellent results in arthroscopic rotator cuff repair are published but little
has been said about complication rates, especially with regard to post
operative stiffness and pain. In our clinic we experience a higher degree of
postoperative pain and shoulder stiffness 3-6 months postoperative in patients
undergoing arthroscopic rotator cuff repair using bio-degradable anchors
compared to titanium or synthetic anchors. The aim of our study was to evaluate
outcomes in early postoperative shoulder stiffness and postoperative pain in
patients undergoing arthroscopic rotator cuff repair, prospectively. The use of
bio-degradable anchors may result in higher rate of postoperative shoulder
stiffness and pain than is associated with the use of titanium or synthetic
anchors in arthroscopic rotator cuff repair. We also want to evaluate
cost-effectiveness of the three different types of anchors used.
Study objective
1. To assess the correlation between the use of bioabsorbable anchors and the
early postoperative rate of shoulder stiffness in comparison to the use of
non-absorbable titanium and synthetic (PEEK) anchors in arthroscopic rotator
cuff repair.
2. To assess the postoperative rate of early shoulder stiffness following
arthroscopic rotator cuff repair.
3. To assess success rate of operation (functional outcome and postoperative
tendon integrity) and complication.
4. To asses differences in postoperative pain and patient satisfaction.
5. To asses cost-effectiveness of the three different types of anchors used.
Study design
Prospective, randomized, controlled study
Intervention
Supraspinatus lesions were repaired using a standardized arthroscopic approach
and a double row technique. Patients were randomized to receive commercially
available absorbable (n=30), titanium (n=30) or synthetic anchors (n=30).
Study burden and risks
The burden for the participants consists of normal outpatient visits of a
proximal 5 minutes: pre operative, 1, 3, 6, 12 weeks, * and 1 year. All
assessments are non-invasive nad standart to patients clinicaly treated before.
To asses shoulder stiffness, pre and postoperative shoulder Range Of Motion
(ROM) will be tested: pre-operative, 3, 6 weeks, 3, 6 and 12 months
postoperative. Patients are asked to fill in the Oxford Shoulder Score a twelve
question questionnaire: pre and 3 months postoperative.
This study does not impose more, peri and postoperative, risk to the patient
than is seen in clinical performed arthroscopic rotator cuff repair. The study
will not provide personal benefits participating patients but future patients
might benefit from the results of the study performed.
Ultimately this will result in more insight in and less postoperative stiffness
in patients undergoing rotator cuff repair
sportlaan 600
Den Haag 2566MJ
NL
sportlaan 600
Den Haag 2566MJ
NL
Listed location countries
Age
Inclusion criteria
- Willing and able to participate in the study protocol
- Age > 18 years
- Diagnosed with a small to medium tear of the supraspinatus tendon, confirmed by ultra sound, symptoms persevering over 6 months despite conservative treatment including physiotherapy, possible subacromial infiltration with corticosteroids and anti inflammatory drugs.
Exclusion criteria
- Unable to give informed concent
- Language barrier
- Frozen shoulder
- Previous surgery to the shoulder or additional injury as in fractures
- Increased surgical risk( ASA >3)
- patients under 18
- diabetes mellitus
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL29749.098.09 |