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Safety Study of Univers® Revers Shoulder Prosthesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Schulthess Klinik
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Hans-Kaspar Schwyzer, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01778777
First received: January 24, 2013
Last updated: August 8, 2014
Last verified: August 2014

January 24, 2013
August 8, 2014
September 2013
July 2015   (final data collection date for primary outcome measure)
SADE within 2 years po [ Time Frame: 2 years po ] [ Designated as safety issue: Yes ]
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%.
Same as current
Complete list of historical versions of study NCT01778777 on ClinicalTrials.gov Archive Site
  • Risk of adverse events intra-operatively, and post-operatively up to 2 years follow-up [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    The following active and passive range of motion parameters will be documented:

    • Abduction
    • Elevation
    • External rotation by 0°
    • External-internal rotation by 90°
Same as current
Not Provided
Not Provided
 
Safety Study of Univers® Revers Shoulder Prosthesis
Safety, Function and Quality of Life in Patient With Rotator Cuff Tear Arthropathy Treated With the Univers® Revers Shoulder Prosthesis

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rotator Cuff Tear Arthropathy
Device: Universe Reverse Prosthesis
Implantation of an universe reverse prosthesis
Experimental: UniverseReverse
Cohort get an universe reverse prosthesis
Intervention: Device: Universe Reverse Prosthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
166
July 2017
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dominik Rickenbacher, MSc +41 44 385 79 77 dominik.rickenbacher@kws.ch
Contact: Laurent Audigé, Dr. PD +41 44 385 75 80 laurent.audige@kws.ch
Switzerland
 
NCT01778777
UniversRevers
Yes
Hans-Kaspar Schwyzer, Schulthess Klinik
Schulthess Klinik
Arthrex, Inc.
Principal Investigator: Hans-Kaspar Schwyzer, Dr. Schulthess Klinik
Schulthess Klinik
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP