Rotator Cuff Tear ArthropathyNCT02084693
COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate
An observational study of Rotator Cuff Tear Arthropathy and Osteoporosis, run by Zimmer Biomet at 5 sites in South Korea.
Trial summary
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Rotator Cuff Tear Arthropathy, Osteoporosis, Osteomalacia
- What is being tested?
- COMPREHENSIVE
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Dec 2013to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Therefore, patients / cases to be included in this study shall utilize the following inclusion criteria: 1. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. 2. Grossly deficient rotator cuff with severe arthropathy and/or * Previously failed shoulder joint replacement with a grossly deficient rotator cuff. * Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or * Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or * Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Who may be able to join
- Patients / cases to be included in this study shall utilize the following inclusion criteria:
- Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.
- The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- Grossly deficient rotator cuff with severe arthropathy and/or
- Previously failed shoulder joint replacement with a grossly deficient rotator cuff.
- Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
- Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
- Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Who cannot join
- The exclusion criteria are the same as the indications stated in the cleared labeling for the device:
- Absolute contraindications include infection, sepsis, and osteomyelitis.
- Relative contraindications include:
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Osteoporosis.
- Metabolic disorders which may impair bone formation.
Show all 9Show fewer
- 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
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Bunndang Seoul Nat'l Univ. Hospital
Seongnam-si, Seongnam
Ewha Womans University Mokdong Hospital
Seoul
Gangnam Sacred Heart Hospital
Seoul
Kyung Hee Univ Hospital
Seoul
Samsung Medical Center
Seoul
About this study
Official title: Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Read the detailed description
The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and Constant Score.
All shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. FDA has cleared this device via Premarket Notification 510(k) K080642. This data collection effort will document the clinical outcomes of the Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
- Being tested
- COMPREHENSIVE
- Medical subject headings
- Rotator Cuff Tear Arthropathy, Osteoporosis, Osteomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMPREHENSIVEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| COMPREHENSIVE | Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Receives: Device: COMPREHENSIVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Measured: 1 year
Secondary outcomes (8)
Adverse Events (including dislocation)
Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Measured: 3 year
Constant-Murley Shoulder Score
Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Measured: 3 year
Radiographic Evaluation (Plain X-ray and CT)
Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Measured: 3 year
Scapular Notching
Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Measured: 3 year
Constant-Murley Shoulder Score
Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Measured: 1 year
Constant-Murley Shoulder Score
Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Measured: 6 Months
Radiographic Evaluation
Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Measured: 1 year
Radiographic Evaluation
Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joo Han Oh, Ph.D., Principal investigator, Bundang Seoul Nat'l University HospitalSang Jin Shin, Ph.D., Principal investigator, Ewha Womans University Mokdong HospitalJae Chul Yoo, Ph. D., Principal investigator, Samsung Medical CenterYong Girl Rhee, Ph.D., Principal investigator, Kyung Hee Univ. HospitalKyu Chul Noh, Ph.D., Principal investigator, Gangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084693
- Sponsor's protocol ID
- INT.CR.GE1
- Status last verified
- Jun 2018
- First submitted
- 5 Mar 2014
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
- ClinicalTrials.gov ID
- NCT02084693
- Acronym / sponsor ID
- INT.CR.GE1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 12 Mar 2014 (estimated)
- 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.
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Detailed description
The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and Constant Score.
All shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. FDA has cleared this device via Premarket Notification 510(k) K080642. This data collection effort will document the clinical outcomes of the Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMPREHENSIVE | – | Device: COMPREHENSIVEEvaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Therefore, patients / cases to be included in this study shall utilize the following inclusion criteria: 1. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. 2. Grossly deficient rotator cuff with severe arthropathy and/or * Previously failed shoulder joint replacement with a grossly deficient rotator cuff. * Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or * Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or * Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Key inclusion criteria (8 listed)
- Patients / cases to be included in this study shall utilize the following inclusion criteria:
- Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.
- The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- Grossly deficient rotator cuff with severe arthropathy and/or
Key exclusion criteria (9 listed)
- The exclusion criteria are the same as the indications stated in the cleared labeling for the device:
- 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.
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 |
|---|---|---|
| COMPREHENSIVEComprehensive® 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. | Device | COMPREHENSIVE |
Primary outcome
Survivorship
Time frame: 1 year
The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
8 secondary outcomes
Adverse Events (including dislocation)
Time frame: 3 year
Constant-Murley Shoulder Score
Time frame: 3 year
Radiographic Evaluation (Plain X-ray and CT)
Time frame: 3 year
Scapular Notching
Time frame: 3 year
Constant-Murley Shoulder Score
Time frame: 1 year
Constant-Murley Shoulder Score
Time frame: 6 Months
Radiographic Evaluation
Time frame: 1 year
Radiographic Evaluation
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Rotator 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.
Joo Han Oh, Ph.D. principal investigator
Bundang Seoul Nat'l University Hospital
Sang Jin Shin, Ph.D. principal investigator
Ewha Womans University Mokdong Hospital
Jae Chul Yoo, Ph. D. principal investigator
Samsung Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear Arthropathy and Osteoporosis, run by Zimmer Biomet at 5 sites in South Korea.
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 8 inclusion and 9 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 5 Jul 2019. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survivorship (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 5 Jul 2019.