Clinical trial NCT05002959: TESS V3 Modular Total Shoulder System PMCF
Official title: Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis Shoulder
Rheumatoid Arthritis
Rheumatoid Arthritis Shoulder
Avascular Necrosis
Revision
Rotator Cuff Tears
Osteonecrosis
Rotator Cuff Tear Arthropathy
Proximal Humeral Fracture
Malunion of Fracture, Shoulder Region
Keywords: Shoulder arthroplasty
Medical device
Performance
Safety
Shoulder prosthesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received a T.E.S.S.® Version 3 Anatomic or Reverse shoulder prosthesis from January 2013, based on the Indications for Use and who meet all of the inclusion and none of exclusion criteria.

Brief 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.

Detailed description: The T.E.S.S.® (Total Evolutive Shoulder System) was developed to provide, with one instrumentation, a complete solution for all indications for shoulder arthroplasty: centered and eccentric rheumatoid osteoarthritis, necrosis, proximal fracture and mal-union of the humeral head. The T.E.S.S.® Modular system can be used in anatomic or reverse configurations with or without the use of a stem, providing a solution for hemi-arthroplasty, total shoulder arthroplasty and revision. The same instrumentation allows implantation of all versions of the T.E.S.S.®.

A maximum of 5 study centers will be involved in Europe. A total number of 146 implants, 73 T.E.S.S.® anatomic and 73 T.E.S.S.® reverse, will be included into the study. Each clinical site will be allowed to enroll a maximum 88 patients (60% of the total study cohort). Ethics Committee (EC) approval has to be obtained prior to conducting this study. All potential subjects will be required to participate in an informed consent process and sign the EC approved written informed consent prior to study enrollment.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient is unwilling or unable to give consent or to comply with the follow-up program
* Patient is known to be pregnant or breastfeeding
* Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant)
* Patient who displays any of the following contra-indications cannot be included in this study:

  * Local or systemic infections
  * Severe muscular, neurological, or vascular deficiency of the affected joint
  * Poor bone quality likely to prevent osseointegration or to affect the long-term stability of the implant (Paget's disease, osteoporosis)
  * Any concomitant conditions likely to affect the function of the implant
  * Allergy to any of the implant components
  * Do not use the modular humeral version (screwed connection) in cases where the corolla cannot be two-thirds covered with bone stock and including the screwed modular stem/corolla junction

Primary outcomes:
measure: Implant survival at 10 years
timeFrame: 10 years
measure: Frequency and incidence of adverse events
timeFrame: 10 years
Secondary outcomes:
measure: Constant and Murley score
timeFrame: 10 years
measure: EQ-5D-5L questionnaire
timeFrame: 10 years
measure: Radiographic Evaluation
timeFrame: 10 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Lyon Ortho Clinic
city: Saint Jean de Védas
country: France
facility: Clinique Saint-Jean (Group ORTHOSUD)
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: