Cuff-tear ArthropathyNCT02466321
Anatomical Shoulder™ Inverse/Reverse Study
A study testing Inverse/Reverse Shoulder Arthroplasty in people with Cuff-tear Arthropathy, run by Zimmer, GmbH at 5 sites in 4 countries.
Trial summary
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs. Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided: Constant and Murley Score to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cuff-tear Arthropathy
- What is being tested?
- Inverse/Reverse Shoulder Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 16 May 2007to 11 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
HELIOS ENDO-Klinik Hamburg
Hamburg
Vitos Orthopädische Klinik Kassel
Kassel
About this study
Official title: Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs.
Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided:
- Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.
Read the detailed description
This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria.
All patients will undergo pre-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge.
There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.
- Conditions
- Cuff-tear Arthropathy
- Being tested
- Inverse/Reverse Shoulder Arthroplasty
- Keywords
- Inverse Reverse Shoulder
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inverse/Reverse Shoulder ArthroplastyProcedure or surgery
Implantation of the Anatomical Shoulder Inverse/Reverse System
| Study group | Role | What they receive |
|---|---|---|
| Inverse / Reverse Shoulder | Experimental | Patient treated with a inverse / reverse shoulder device. Receives: Procedure: Inverse/Reverse Shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Performance
Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
Measured: 10 years
Secondary outcomes (1)
Survival (Kaplan-Meier)
The Kaplan-Meier estimator is a non-parametric statistic used to estimate the survival function from lifetime data. It is used to measure the fraction of patients living (in this case without a revision surgery) for a certain amount of time after treatment. A higher score is a better outcome.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start16 May 2007
- Primary completion16 Feb 2022
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cuff-tear ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer, GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elliott Goff, PhD, Study chair, Zimmer Biomet, Jr. Clinical Project Lead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466321
- Sponsor's protocol ID
- 06-U02
- Status last verified
- Feb 2025
- First submitted
- 3 Jun 2015
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
- ClinicalTrials.gov ID
- NCT02466321
- Acronym / sponsor ID
- 06-U02
- Conditions
- Cuff-tear Arthropathy
- Keywords
- Inverse Reverse Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Zimmer, GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 May 2007 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs.
Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided:
- Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.
Detailed description
This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria.
All patients will undergo pre-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge.
There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inverse / Reverse Shoulder | Experimental | Procedure: Inverse/Reverse Shoulder ArthroplastyPatient treated with a inverse / reverse shoulder device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inverse/Reverse Shoulder ArthroplastyImplantation of the Anatomical Shoulder Inverse/Reverse System | Procedure or surgery | Inverse / Reverse Shoulder |
Primary outcome
Functional Performance
Time frame: 10 years
Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
1 secondary outcome
Survival (Kaplan-Meier)
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cuff-tear Arthropathy
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Enrolling by invitationPhase 1
Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
Rotator Cuff Tears, Rotator Cuff Injuries
Enrolling by invitation
Patient Education and Sling Use After Shoulder Surgery
Rotator Cuff Tear, Sling
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliott Goff, PhD study chair
Zimmer Biomet, Jr. Clinical Project Lead
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inverse/Reverse Shoulder Arthroplasty in people with Cuff-tear Arthropathy, run by Zimmer, GmbH at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Belgium, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Performance (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.