Multi Centre Study on TESS V2 Shoulder System

NCT03431857 | Completed Results

• 1 other identifier: ORTHO.CR.E13
• Study Type: observational
• Target: 106
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Osteoarthritis Shoulder; Fracture; Rheumatoid Arthritis; Avascular Necrosis; Rotator Cuff Tear; Revision

Keywords

Shoulder arthroplasty; Medical device; Shoulder prosthesis; Performance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Active Anterior Elevation

  Pre-operative, 5 years follow-up

• Active Lateral Elevation

  Pre-operative, 5 years follow-up

• Active External Rotation RE1

  Pre-operative, 5 years follow-up

• Active External Rotation RE2

  Pre-operative, 5 years follow-up

• Passive Elevation

  Pre-operative, 5 years follow-up

Study Arms (1)

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

Interventions

TESS V2 DEVICE

Patients requiring the TESS V2 prosthesis.

TESS V2 Prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Orthokliniek Waasland

Sint-Niklaas, 9100, Belgium

Location

Institut Calot

Berck, 59, France

Location

MeSH Terms

Conditions

Fractures, Bone; Arthritis, Rheumatoid; Osteonecrosis; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rupture; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Emilie Rohmer, Clinical Ops manager
• Organization: Zimmer Biomet

emilie.rohmer@zimmerbiomet.com

+41588548210

Study Officials

• Paola Vivoda

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 13, 2018
• Study Start: October 20, 2010
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2019
• Last Updated: October 19, 2021
• Results First Posted: October 19, 2021

Record last verified: 2021-09

Locations

BE (1); FR (1)