Arthropathy of Shoulder RegionNCT03404778
Comprehensive Reverse Shoulder Data Collection
An observational study of Arthropathy of Shoulder Region and Grossly Deficient Rotator Cuff, run by Zimmer Biomet at 4 sites in United States.
Trial summary
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder
- What is being tested?
- Biomet Comprehensive Reverse Shoulder
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Mar 2010to Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients in need of a reverse shoulder arthroplasty which receive the Biomet Comprehensive Reverse Shoulder and who meet all of the inclusion and none of the exclusion criteria.
Who may be able to join
- Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
- The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Who cannot join
- Absolute contraindications include infection, sepsis, and osteomyelitis.
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Osteoporosis.
- Metabolic disorders which may impair bone formation.
- Osteomalacia.
- Distant foci of infections which may spread to the implant site.
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Allina Health System DBA Sports and Orthopaedic Specialists
Edina, Minnesota, 55439
Joint Implant Surgeons
New Albany, Ohio, 43054
William Beaumont Hospital
Royal Oak, Michigan, 48073
Acromion LLC
Towson, Maryland, 21204
About this study
Official title: Comprehensive Reverse Shoulder Clinical Outcomes Study
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.
Read the detailed description
The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain.
This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects, Post-Traumatic Arthitis
- Being tested
- Biomet Comprehensive Reverse Shoulder
- Keywords
- Reverse Shoulder Arthroplasty, Medical Device, Performance, Safety, Shoulder Prosthesis, Glenoid Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomet Comprehensive Reverse ShoulderDevice
Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation.
| Study group | Role | What they receive |
|---|---|---|
| Biomet Comprehensive Reverse Shoulder | Subjects in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Shoulder System. Receives: Device: Biomet Comprehensive Reverse Shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with "None" as the best outcome and "Severe" as the worst. Improvement of pain score at one year from pre-operative levels will be assessed.
Measured: 1 year
Secondary outcomes (2)
Constant Shoulder Score
The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.
Measured: Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
Presence of Scapular Notching
All radiographic images collected during the study are assessed by the Principal Investigator for the presence of scapular notching. The severity of notching will be assessed using the Nerot system, where Grade 0 indicates no notch and Grade 4 indicates the largest-sized defect in the scapula.
Measured: 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start7 Mar 2010
- Primary completionDec 2026 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of Shoulder RegionStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404778
- Sponsor's protocol ID
- ORTHO.CR.EX007
- Status last verified
- Oct 2025
- First submitted
- 12 Jan 2018
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Reverse Shoulder Clinical Outcomes Study
- ClinicalTrials.gov ID
- NCT03404778
- Acronym / sponsor ID
- ORTHO.CR.EX007
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects, Post-Traumatic Arthitis
- Keywords
- Reverse Shoulder Arthroplasty, Medical Device, Performance, Safety, Shoulder Prosthesis, Glenoid Erosion
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2010 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.
Detailed description
The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain.
This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomet Comprehensive Reverse Shoulder | – | Device: Biomet Comprehensive Reverse ShoulderSubjects in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Shoulder System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of a reverse shoulder arthroplasty which receive the Biomet Comprehensive Reverse Shoulder and who meet all of the inclusion and none of the exclusion criteria.
Key inclusion criteria (3 listed)
- Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
- The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Key exclusion criteria (7 listed)
- Absolute contraindications include infection, sepsis, and osteomyelitis.
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Osteoporosis.
- Metabolic disorders which may impair bone formation.
- Osteomalacia.
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 |
|---|---|---|
| Biomet Comprehensive Reverse ShoulderDesigned to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation. | Device | Biomet Comprehensive Reverse Shoulder |
Primary outcome
Pain Score
Time frame: 1 year
Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with "None" as the best outcome and "Severe" as the worst. Improvement of pain score at one year from pre-operative levels will be assessed.
2 secondary outcomes
Constant Shoulder Score
Time frame: Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
Presence of Scapular Notching
Time frame: 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
Related trials for Arthropathy of Shoulder Region
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Not yet recruiting
Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
RecruitingObservational study
Acromial Morphology: Reliability of CT-based Assessment and Relationship With Age in a Series of 420 Patients
Shoulder Impingement Syndrome, Acromial Morphology
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Shoulder Region and Grossly Deficient Rotator Cuff, run by Zimmer Biomet at 4 sites in United States.
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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain Score (time frame: 1 year). 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 30 Oct 2025.