Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)

Status: Active_not_recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is 18 years or older and skeletally mature

• Patient is capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program

• Patient gave consent to take part in the study by signing the Informed Consent Form

• Patient operated from January 2013 and received the Anatomic or Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function

• Patient has adequate quality and quantity of bone stock to support the prosthesis

• Patient meets at least one of the following indications:

⁃ For anatomic type:

• Centered osteoarthritis of the shoulder

• Humeral head fractures

• Rheumatoid arthritis (with intact rotator cuff)

• Avascular necrosis of the humeral head

• Revision of a hemi-arthroplasty with a total arthroplasty

• Revision of a reverse prosthesis with an anatomic prosthesis

• Revision to increase the size of the stem (length and/or diameter)

• Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis

⁃ For reverse type:

• Offset osteoarthritis of the shoulder

• Massive and non-repairable rotator cuff tears

• Rheumatoid arthritis (with degenerative rotator cuff)

• Revision of an anatomic prosthesis with a reverse prosthesis

• Revision to increase the size of the stem (length and/or diameter)

• Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis

Locations
Other Locations
France
Lyon Ortho Clinic
Lyon
Clinique Saint-Jean (Group ORTHOSUD)
Saint-jean-de-védas
Time Frame
Start Date: 2022-02-01
Completion Date: 2026-12
Participants
Target number of participants: 67
Treatments
TESS Anatomic
Subjects who received the Anatomic T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria.
TESS Reverse
Subjects who received the Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria.
Sponsors
Leads: Zimmer Biomet

This content was sourced from clinicaltrials.gov