Study of functional outcome after arthroscopic tenotomy of long head biceps tendon vs. arthroscopic debridement vs. conservative treatment as treatment for degenerative rotator cuff ruptures in patients 65 years or older.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the Constant-Murley Score. With this as outcome
measure we can compare the results to the current literature.
Secondary outcome
Secondary outcome is the Oxford Shoulder Score. Other questionnaires/tests
where patients will be exposed to are the VAS pain score, EQ-5D questionnaire,
Anchor questions questionnaire and the O'Brien test at the physical
examination. We will also determine the size and anatomical location of the
rotator cuff rupture on the MRI.
Background summary
A rupture of the rotator cuff is very common. In older patients, the risk of
re-rupture after surgical repair is larger and the functional outcome less
compared to surgical repair in younger patients. Symptomatic lesions of the
long biceps tendon are common in patients with large rotator cuff ruptures due
to clamping of the long biceps tendon between the acromion and the humeral
head. Earlier research showed that after a spontaneous rupture of the long
biceps tendon in general an improvement of the shoulder complaints occurred
after a short period of acute pain. For those elderly patients where extensive
rotator cuff repair is not a good option anymore, an arthroscopic tenotomy of
long head biceps tendon could be an option. To date there is no evidence of how
these patients to be treated the best.
Study objective
Study of functional outcome after arthroscopic tenotomy of long head biceps
tendon vs. arthroscopic debridement vs. conservative treatment as treatment for
degenerative rotator cuff ruptures in patients 65 years or older.
Study design
Prospective randomized multicenter study where 126 patients will be enrolled in
7 centers with follow-up of 1 year. Randomization of the 3 treatment arms will
be achieved equally by block randomization. Conservative treatment starts
immediately after inclusion, surgical treatment within 6 weeks after inclusion.
In addition to the baseline measurements, there will be times of measurements
at 6 weeks, 3 months, 6 months and 12 months.
Intervention
Not applicable.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Since all three treatments are regular
treatments for this patient category, there are no higher risks to expect
compared to the usual care. At the measurement moments 15 minutes are extra
calculated to fill out the questionnaires. The O'Brien test is performed once
before initiating treatment at the physical examination, but this is a normal
treatment. A MRI scan is normal care for this patient category and is no
additional burden for the patient. With a minimal effort of the patient we can
require a maximum of information to obtain de best possible care for this
patient group. This is important, because there is no good treatment for this
disease.
Berkelstraat 3
Groningen 7925 GT
NL
Berkelstraat 3
Groningen 7925 GT
NL
Listed location countries
Age
Inclusion criteria
1) Age 65 years and older.
2) Clinical suspicion rotator cuff rupture with pain and/or weakness while testing supraspinatus tendon and/or infraspinatus tendon.
3) MRI of the affected shoulder, assessed by two evaluators as full thickness suprasprinatus and/or infraspinatus rupture with retraction at least grade 2 according to the scale of Patte and intact non-dislocated long head biceps tendon.
4) Signed informed consent.
Exclusion criteria
1) Frozen shoulder (in more than 3 directions less than 50% of the normal range of motion, passive examination)
2) Symptomatic AC-artrosis on the ipsilateral side.
3) (Reumatoïd) arthritis
4) Diabetes Mellitus (type 1 and 2).
5) Language barrier or cognitive problem (not able to fill in the questionnaires).
5) Neurologic problems with functional shoulder complaints.
6) Surgical treatment in the past in the same shoulder.
7) Glenohumoral osteoarthritis
8) Inclusion of the contralateral shoulder in this study.
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 | NL54517.075.15 |
| Other | NTR-nummer volgt. |