Anatomical Shoulder™ Inverse/Reverse Study

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT02466321
• Date of registration: 03/06/2015
• Prospective Registration: No
• Primary sponsor: Zimmer, GmbH
• Public title: Anatomical Shoulder™ Inverse/Reverse Study
• Scientific title: Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
• Date of first enrolment: September 2005
• Target sample size: 160
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02466321
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Germany, Switzerland, United Kingdom

Contacts

• Name: Elliott Goff, PhD
• Affiliation: Zimmer Biomet, Jr. Clinical Project Lead

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age - 18 years minimum.

- Sex - male and female.

- General Health - the patient should be able to undergo surgery and participate in a
follow-up program based upon physical examination and medical history.

- Informed Consent - patient or patient's legal representative has signed a Patient
Informed Consent form.

- Indications - Diagnosis of disease or trauma in the affected joint, including
cuff-tear arthropathy, failure of prior rotator cuff surgery and irreparable rotator
cuff tears associated with loss of glenohumeral stability with the indication for
total shoulder arthroplasty.

- The deltoid muscle has to be intact in all 3 parts (clavicular, acromial as well as
spinal).

Exclusion Criteria:

- Patient is skeletally immature.

- Patient is pregnant.

- Patient is unwilling or unable to cooperate in a follow-up program.

- Patient shows one of the following medical conditions - Chronic fracture, Acute
fracture, Axillary nerve lesion, Severe loss of humeral or glenoid bone, Paralysis of
the deltoid muscle, Active Infection

- Patient requires one of the following medical interventions - Implant Revision,
Glenoid bone grafting, Autografts



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cuff-tear Arthropathy

Intervention(s)

Procedure: Inverse/Reverse Shoulder Arthroplasty

Primary Outcome(s)

Functional Performance [Time Frame: 10 years]

Secondary Outcome(s)

Survival [Time Frame: 10 years]

Secondary ID(s)

06-U02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors