Multi Centre Study on TESS V2 Shoulder System

Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System

This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Rotator Cuff Tear; Avascular Necrosis; Fracture; Osteoarthritis Shoulder; Revision
• Intervention / Treatment: Device: TESS V2

Detailed Description

The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Belgium
  • Sint-Niklaas, Belgium, 9100
    • Orthokliniek Waasland
• France
  • Berck, France, 59
    • Institut Calot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in need of Total Shoulder Arthroplasty (primary or revision) who receive the TESS V2 and who meet all of the inclusion and none of the exclusion criteria.

Description

Inclusion Criteria:

• Except in special cases, the "anatomic" type is indicated for:

  • Centered osteoarthritis of the shoulder
  • Humeral head fractures
  • Rheumatoid arthritis (with intact rotator cuff)
  • Avascular necrosis of the humeral head

• Except in special cases, the "reversed" type is indicated for:

  • Offset osteoarthritis of the shoulder
  • Massive and non-repairable rotator cuff tears
  • Rheumatoid arthritis (with degenerative rotator cuff)

• Revision in cases of:

  • Replacement of an "anatomic" prosthesis with a "reversed" prosthesis
  • Conversion of a hemi-arthroplasty into a total arthroplasty
  • Increasing the size of the stem (length and/or diameter)
  • Replacing a glenoid prosthesis
  • Replacing a competitor's prosthesis
  • In rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis

• Additional inclusion criteria include

  • Patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements)
  • Willing to return for follow-up evaluations

Exclusion Criteria:

• Local or systemic infections.
• Severe muscular, neurological, or vascular deficiency of the affected joint.
• Bone destruction or poor bone quality liable to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
• Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.
• Any concomitant complaint likely to affect the functioning of the implant.
• Allergy to any of the implant components.
• Local bone tumors.
• Patient over 18 under law supervision

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TESS V2 Prosthesis; Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.	Device: TESS V2; Patients requiring the TESS V2 prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Shoulder Score	The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.	Pre-operative, 5 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Anterior Elevation	The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active anterior elevation measures the extent to which a patient can elevate the arm anteriorly and is here reported in degrees.	Pre-operative, 5 years follow-up
Active Lateral Elevation	The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active lateral elevation measures the extent to which a patient can elevate the arm laterally and is here reported in degrees.	Pre-operative, 5 years follow-up
Active External Rotation RE1	The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE1 measures the extent to which a patient can rotate the bent arm externally and is here reported in degrees.	Pre-operative, 5 years follow-up
Active External Rotation RE2	The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE2 measures the extent to which a patient can rotate the arm externally from a position of 90° of abduction and is here reported in degrees.	Pre-operative, 5 years follow-up
Passive Elevation	The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive elevation measures the extent to which the arm of the patient can be passively elevated in the plane of the scapula and is here reported in degrees.	Pre-operative, 5 years follow-up
Passive External Rotation	The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive external rotation elbow to body (RE 1) measures the extent to which the bent arm of the patient can be passively rotated externally and is here reported in degrees.	Pre-operative, 5 years follow-up
Radiographic Evaluation	A complete radiographic evaluation (front view 3 rotations, lateral view) is completed pre-operatively. For the post-operative radiographic evaluations, the form is simplified and contains two options: "unchanged" or "changed" when compared to the preoperative x-ray, with presence of radiolucencies and/or notching. The number of "changed" radiographic evaluations per time point are here reported.	Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up.
Survivorship	The Kaplan-Meier method is used to report implant survivorship. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 5 years post-operatively.	5 years follow-up

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2010
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Shoulder arthroplasty; Performance; Medical device; Shoulder prosthesis
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Necrosis
• Other Study ID Numbers: ORTHO.CR.E13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No