Safety Study of Univers® Revers Shoulder Prosthesis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01778777|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2013
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear Arthropathy||Device: Universe Reverse Prosthesis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Function and Quality of Life in Patient With Rotator Cuff Tear Arthropathy Treated With the Univers® Revers Shoulder Prosthesis|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Cohort get an universe reverse prosthesis
Device: Universe Reverse Prosthesis
Implantation of an universe reverse prosthesis
- SADE within 2 years po [ Time Frame: 2 years po ]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%.
- Risk of adverse events intra-operatively, and post-operatively up to 2 years follow-up [ Time Frame: 2 years ]
As typically one single surgery should be sufficient to treat the patient, all secondary surgical interventions should be revisions due to a complication.
The occurrence and time of revision surgery (implant survival) will be described by Kaplan-Meier curve.
- Prosthesis survival at 2, 5 and 10 years [ Time Frame: 2, 5 and 10 years ]All Patients with a prosthesis revision will be documented along with the date of revision. At each follow up time point the proportion of patients with prosthesis revision will be estimated. Time to prosthesis revision will be examined by survival methods to account for censored data.
- Constant (Murley) score (CS) [ Time Frame: 6mo, 1, 2, 5 and 10 years ]The Constant (Murley) score is possibly the most commonly used tool for assessment of shoulder function. The physician asks and documents answers to QOL questions (pain and ADL, ability to work, sleep, sports and leisure) and certain clinical parameters (active ROM, abduction strength). The different scales will be summed and normalized to O=worst to 100= best. A German version is available for clinical use. Investigators are obliged to use a spring balance for the force measurements. Only one measurement per patient per assessment will be done.
- The Shoulder Pain and Disability Index (SPADI) [ Time Frame: 6mo, 1, 2, 5 and 10 years ]The Shoulder Pain and Disability Index (SPADI) is a short, self-administered questionnaire that provides an item scoring by a visual analogue scale (VAS) from 0 (no pain/no difficulty, i.e. best) to 11 (worst pain imaginable/so difficult required help, i.e. worst). Five items assess pain and 8 items disability of the arm (function). The unweighted means of the 5 pain and the 8 function items will be transformed into the scale from 0 (=worst) to 100 (=best) for both scales and are used to determine pain and function scores. The average of these two scores then gives the total SPADI score. A validated German version is available.
- Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH) [ Time Frame: 6mo, 1, 2, 5 and 10 years ]The Disability of the Arm, Shoulder and Hand questionnaire (DASH) is a comprehensive self-administered questionnaire about symptoms and functioning of the entire upper extremity. The DASH enquires about the ability to perform simple and complex activities of daily living (ADL) that are commonly performed with either one or both arms. The total score is derived from the unweighted mean of 30 items, of which at least 27 have to be answered. The QuickDASH is a more efficient version of the DASH outcome measure that appears to retain its measurement properties. It contains eleven items and is similar with regard to scores and properties to the full DASH. A validated full-length German version is available that can be used in the shortened version.
- EuroQoL EQ-5D-5L [ Time Frame: 6wk, 6mo, 1, 2, 5 and 10 years ]The EQ-5D is a widely used instrument to measure and value generic health (status). It is based on a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. The instrument is designed for self-completion, and patients also rate their overall health on the day of the interview on a 0-100 visual analogue scale (EQ-VAS).
- Patient satisfaction [ Time Frame: 6wk, 6mo, 1, 2, 5 and 10 years ]In order to obtain an overall assessment of the arthroplasty result, patients will be asked to assess their current state of health in general related to the operated shoulder joint at the follow-up compared to the state before the arthroplasty. This so-called 'transition' question has the possible answers 'much worse', 'slightly worse', 'equal', 'slightly better', and 'much better'. Patients also rate their level of satisfaction, with the help of a numeric rating scale (NRS: 0-10), in terms of how the outcome met up to their preoperative expectations of the arthroplasty. Finally, they will be asked whether - with their current knowledge of the outcome - they would again choose the operation if they found themselves in similar circumstances to those which prevailed preoperatively.
- Radiographic Parameters [ Time Frame: 6mo, 1, 2, 5 and 10 years ]
Three radiographs should be taken at each study visit: AP view in internal and external rotation and axial view. The images will be collected digitally and centralized for latter evaluation by an independent reviewer based on the radiographic assessment CRF developed by the Schulthess clinic, including the following parameters:
- Scapular notching
- Signs of osteolysis at the glenoid and at the stem
- Status of tuberculum majus and minus
- Glenoid migration
- Glenoid component seating
- Stem position
- Change of relative position of components
- Ectopic bone formation
- Cortical bone resorption
- Prosthesis breakage
- Rotation failure
- Luxation of the prosthesis
- PE Wear of the metaglene
- PE Dissociation
- Patient active and passive range of motion (ROM) and shoulder strength [ Time Frame: 6mo, 1, 2, 5 and 10 years ]
The following active and passive range of motion parameters will be documented:
- External rotation by 0°
- External-internal rotation by 90°
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778777
|Zürich, Kanton Zürich, Switzerland, 8008|
|Principal Investigator:||Hans-Kaspar Schwyzer, Dr.||Schulthess Klinik|