To compare the functional results of LHB tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient evaluation is conducted with a focus on overall shoulder function, as
evaluated with the Constant score. In addition, the Dutch Oxford Shoulder Test
and the Disabilities of the Arm Shoulder and Hand questionnaire will be
assessed.
Secondary outcome
Other evaluations concern: cosmetic appearance evaluated by the **Popeye**
deformity, arm cramping pain, elbow flexion strength (measured with a hand
dynamometer), and quality of life and cost-utility (evaluated with the EQ-5D).
Background summary
During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps
tendon lesions are frequently encountered. However, the most optimal treatment
of the diseased long head of the biceps (LHB) tendon during rotator cuff repair
remains a topic of debate: tenotomy or tenodesis. Our hypothesis is that there
is no difference in functional outcome between LHB tenotomy and LHB tenodesis
when performed in adjunct to arthroscopic rotator cuff repair.
Study objective
To compare the functional results of LHB tenotomy and LHB tenodesis when
performed in adjunct to arthroscopic rotator cuff repair.
Study design
An International, Multicenter, Prospective Randomized Controlled Trial
Intervention
In addition to arthroscopic rotator cuff repair one group is treated by
performing LHB tenotomy and the other group is treated by performing an LHB
tenodesis.
Study burden and risks
We do not anticipate treatment related risks related to participation in this
study, but it is possible (though unlikely) that one treatment method will
prove inferior to the other with respect to postoperative functional outcome or
satisfaction. Treatment of LHB tendon lesions is performed differently around
the world. Studies addressing the differences in outcome between the two
treatment variations showed comparable results. If this study confirms our
hypothesis, our patients will not have to undergo LHB tenodesis. This
potentially avoids complications associated with an added procedure of the LHB
tenodesis to an arthroscopic rotator cuff repair. This is probably less costly
in terms of time and material as well.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
Patients older than 50 years who are indicated to undergo repair of a moderately sized rotator cuff (infraspinatus and/or supraspinatus) tendon rupture (sized smaller than 3cm measured using an arthroscopic ruler), who are encountered with an inflamed, unstable or partially torn LHB tendon.
Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.
Exclusion criteria
Patients are excluded form this study in case of an acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler.
Patients are also excluded when the origo of the bicepstendon has an hour-glass aspect or in case of accompanying subscapularis tendon rupture.
Pre-operative X-ray of the involved shoulder revealing acromion to humeral head distance measuring 6mm or smaller or osteoarthritis also excludes patients from participation to this study.
Any prior surgery to the involved shoulder leads to exclusion from participation in this study. Dementia or inability to complete questionnaires and assessments excludes patients form this study as well.
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 | NL37898.100.11 |