Trial Review

This is a test website


Please note the ANZCTR will be unattended on Monday the 27th of January due to the national public holiday.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05002959




Registration number
NCT05002959
Ethics application status
Date submitted
5/08/2021
Date registered
12/08/2021
Date last updated
1/10/2024

Titles & IDs
Public title
TESS V3 Modular Total Shoulder System PMCF
Scientific title
Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)
Secondary ID [1] 0 0
CME2019-44E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis Shoulder 0 0
Rheumatoid Arthritis 0 0
Rheumatoid Arthritis Shoulder 0 0
Avascular Necrosis 0 0
Revision 0 0
Rotator Cuff Tears 0 0
Osteonecrosis 0 0
Rotator Cuff Tear Arthropathy 0 0
Proximal Humeral Fracture 0 0
Malunion of Fracture, Shoulder Region 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Anatomic TESS V3
Treatment: Devices - Reverse TESS V3

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.


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

Treatment: Devices: Reverse TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant survival at 10 years
Timepoint [1] 0 0
10 years
Primary outcome [2] 0 0
Frequency and incidence of adverse events
Timepoint [2] 0 0
10 years
Secondary outcome [1] 0 0
Constant and Murley score
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
EQ-5D-5L questionnaire
Timepoint [2] 0 0
10 years
Secondary outcome [3] 0 0
Radiographic Evaluation
Timepoint [3] 0 0
10 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Lyon
Country [2] 0 0
France
State/province [2] 0 0
Saint Jean de Védas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hassan Achakri
Address 0 0
Zimmer Biomet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05002959