To investigate the effect of superior capsular reconstruction in patients with an irreparable degenerative rotator cuff tear on pain and function. Secondary, complications will be monitored and radiographic analyses performed as safety measures.
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
The main study parameter is the functional outcome, measured using the
Constant-Murley score (including a patient questionnaire and measurements of
Range of Motion and muscular strength).
This will be measured pre-operatively and at 3, 6, 12 and 24 months
post-operatively as well as 5 and 10 years post-operatively.
Secondary outcome
Furthermore, pain (NRS-score), function (Disabilities of Arm Shoulder and Hand
(DASH) questionnaire) and quality of life (SF12) will be measured and X-rays
will be taken to evaluate possible (re)tears.
All parameters will be measured pre-operatively and at 3, 6, 12 and 24 months
post-operatively, as well as 5 and 10 years post-operatively. Only the
radiographs at 3 months will not discarded, since an X-ray is already taken
directly post-opeartive, conform standard care.
Background summary
Degenerative rotator cuff tears are common in the elderly and can cause serious
pain and functional limitation. When conservative treatment fails,
(arthroscopic) rotator cuff repair can be considered. In case of a massive
rotator cuff tear, primary rotator cuff repair is not possible and a reversed
shoulder prosthesis can be considered. This is an invasive surgery, with an
increased risk of serious complications and no guarantee of complete recovery
of function.
Superior capsular reconstruction is a new technique that enables to recover the
superior capsule by suturing an *acellular dermal matrix* to the glenoid and
the humeral head to overcome the rotator cuff tear. This technique is
joint-saving and therefore less invasive and presumably has a lower chance of
complications than a reversed shoulder prosthesis. This technique is now
standard-of-care in VieCuri Medical Centre and clinc ViaSana. Superior capsular
reconstruction can be performed with different types of*acellular dermal
matrix, namely porcine graft or human graft. For both types of allografts the
first results of superior capsular reconstruction are promising, but until now,
long term results are unknown.
We hypothesize superior capsular reconstruction results in a decline of pain
and restoration of function without severe complications, and no significant
differences in primary and secondary outcomes will be found between the two
types of allografts.
Study objective
To investigate the effect of superior capsular reconstruction in patients with
an irreparable degenerative rotator cuff tear on pain and function. Secondary,
complications will be monitored and radiographic analyses performed as safety
measures.
Study design
Non-comparative prospective observational follow-up study
Intervention
Arthroscopic superior capsular reconstruction. Through an arthroscopic surgical
procedure, an acellular dermal matrix is sutured to the glenoid and the head of
the humerus to overcome the rotator cuff tear.
Study burden and risks
The measurement of pain and function outcomes necessary for this study is
standard care for all patients that undergo surgery for shoulder pathology,
except for the muscle strength and questionnaires, and for 3 additional visits
(at 2, 5 and 10 years post-operatively). Furthermore, patients receive four
additional X-rays (at 1,2,5 and 10 years post-operatively). Additional
measurements and X-rays will be combined with regular care visits as much as
possible to limit the impact of the study related activities on participants.
Tegelseweg 210
Venlo 5912 BL
NL
Tegelseweg 210
Venlo 5912 BL
NL
Listed location countries
Age
Inclusion criteria
Age > 40 years;
Patiënts with a clinical suspicion of a rotator cuff tear scheduled for
arthroscopic superior capsular reconstruction;
Patients have signed informed consent.
Exclusion criteria
Patients with rheumatoid arthritis
The inability to understand Dutch language
Patients with neurologic impairment influencing functioning affected limb
Design
Recruitment
Medical products/devices used
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 | NL63564.068.17 |