Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05002959
Other study ID # CME2019-44E
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date September 2028

Study information

Verified date May 2024
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 67
Est. completion date September 2028
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Anatomic TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration.
Reverse TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.

Locations

Country Name City State
France Lyon Ortho Clinic Lyon
France Clinique Saint-Jean (Group ORTHOSUD) Saint Jean de Védas

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implant survival at 10 years The functional performance and clinical benefits will be determined by assessing the survival of the implant at 10 years using the Kaplan-Meier method. The survivorship of the implanted device will be recorded from the date of implantation to the date of revision or intended revision up to 10 years post-operatively. 10 years
Primary Frequency and incidence of adverse events The safety will be assessed by monitoring the frequency and incidence of adverse events.
Adverse events will be collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
10 years
Secondary Constant and Murley score The functional performance and clinical benefits will be assessed by the Constant and Murley score.
The Constant Murley score is a 100-points scale composed of a number of individual parameters. These parameters define 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 (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
10 years
Secondary EQ-5D-5L questionnaire The functional performance and clinical benefits will be evaluated by collecting the patient-filled EQ-5D-5L questionnaire.
EQ-5D-5L is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score, with higher scores indicating higher health utility. The second part of the EQ-5D-5L questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
10 years
Secondary Radiographic Evaluation The functional performance and clinical benefit will be evaluated by analyzing the post-operative radiographic parameters (radiolucency, osteolysis, osteophytes, component migration and heterotopic ossification). At each post-operative follow-up visit, the radiographies will be evaluated and any finding will be collected in a Radiographic Evaluation Form. 10 years
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4