Clinical trial NCT01778777: Safety Study of Univers® Revers Shoulder Prosthesis
Official title: Safety, Function and Quality of Life in Patient With Rotator Cuff Tear Arthropathy Treated With the Univers® Revers Shoulder Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear Arthropathy
Keywords: rotator cuff tear arthropathy
inverse prosthesis
safety
universe reverse
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2013-01-29
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.

Detailed description: Reverse shoulder arthroplasty and its principles are still recognized today as the gold standard for treatment of degenerative arthropathy of the shoulder associated with an irreparable tear of the rotator cuff. The new Arthrex Univers® Revers Shoulder Prosthesis shows a large and narrow range of components, whether it is a stem, cup, spacer, inlay or glenosphere. Adjustment can be done in very small steps to match anatomic and biomechanic needs. The Arthrex Univers Revers Shoulder Prosthesis is the only device up to date that can be configured in two different inclination angles without any limitation in component use.

This multicentre case-series has the goal to evaluate whether patients with rotator cuff tear arthropathy benefit from the Univers® Revers shoulder prosthesis in terms of low complication risk, as well as high function and quality of life.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years and over
* Patient with primary omarthrosis or secondary osteoarthritis associated with insufficiency in the centering function of the rotator cuff

and

• Willing and able to give written informed consent to participate in the study including all follow-up examinations

Exclusion Criteria:

* Previous ipsilateral shoulder arthroplasty
* Acute shoulder trauma
* Post-traumatic secondary osteoarthritis
* Rheumatoid arthritis
* General medical contraindication to surgery
* Known hypersensitivity to the materials used
* Tumour / malignoma
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Bacterial infection at the time point of operation
* Recent history of substance abuse
* Legal incompetence
* Pregnancy or
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Primary outcomes:
measure: SADE within 2 years po
timeFrame: 2 years po
Secondary outcomes:
measure: Risk of adverse events intra-operatively, and post-operatively up to 2 years follow-up
timeFrame: 2 years
measure: Prosthesis survival at 2, 5 and 10 years
timeFrame: 2, 5 and 10 years
measure: Constant (Murley) score (CS)
timeFrame: 6mo, 1, 2, 5 and 10 years
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: 6mo, 1, 2, 5 and 10 years
measure: Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)
timeFrame: 6mo, 1, 2, 5 and 10 years
measure: EuroQoL EQ-5D-5L
timeFrame: 6wk, 6mo, 1, 2, 5 and 10 years
measure: Patient satisfaction
timeFrame: 6wk, 6mo, 1, 2, 5 and 10 years
measure: Radiographic Parameters
timeFrame: 6mo, 1, 2, 5 and 10 years
measure: Patient active and passive range of motion (ROM) and shoulder strength
timeFrame: 6mo, 1, 2, 5 and 10 years
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
state: Kanton Zürich
Study officials:
affiliation: Schulthess Klinik
name: Hans-Kaspar Schwyzer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: