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CompletedNCT02084693Updated Jul 5, 2019

COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

An observational study in Rotator Cuff Tear Arthropathy, Osteoporosis and Osteomalacia, sponsored by Zimmer Biomet. Completed at 5 sites in Korea, Republic of. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Zimmer Biomet · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
60 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rotator Cuff Tear Arthropathy
  • Osteoporosis
  • Osteomalacia
  • Joint; Destruction, Sacroiliac
03

In context

Rotator Cuff Tear Arthropathy

57 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.

This study's enrollment of 100 is below the median of 150 across 21 observational studies indexed under Rotator Cuff Tear Arthropathy.

Browse Rotator Cuff Tear Arthropathy studies →

Lead sponsor

Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.

Browse Zimmer Biomet studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients / cases to be included in this study shall utilize the following inclusion criteria:

  1. Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.
  2. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

  3. Grossly deficient rotator cuff with severe arthropathy and/or

    1. Previously failed shoulder joint replacement with a grossly deficient rotator cuff.
    2. Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
    3. Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
    4. Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Exclusion criteria

Exclusion Criteria:

  • The exclusion criteria are the same as the indications stated in the cleared labeling for the device:

Absolute include infection, sepsis, and osteomyelitis.

Relative contraindications include:

  1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
  2. Osteoporosis.
  3. Metabolic disorders which may impair bone formation.
  4. Osteomalacia.
  5. Distant foci of infections which may spread to the implant site.
  6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • COMPREHENSIVE

    Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

    Device: COMPREHENSIVE

Interventions

  • DeviceCOMPREHENSIVE

    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.

06

What researchers measure

Primary outcomes

  1. Survivorship

    The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

    Time frame: 1 year

Secondary outcomes

  1. Adverse Events (including dislocation)

    Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes

    Time frame: 3 year

  2. Constant-Murley Shoulder Score

    Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes

    Time frame: 3 year

  3. 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

    Time frame: 3 year

  4. Scapular Notching

    Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes

    Time frame: 3 year

  5. Constant-Murley Shoulder Score

    Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes

    Time frame: 1 year

  6. Constant-Murley Shoulder Score

    Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes

    Time frame: 6 Months

  7. Radiographic Evaluation

    Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes

    Time frame: 1 year

  8. Radiographic Evaluation

    Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes

    Time frame: 6 Weeks

07

Study locations

5 sites
  • Bunndang Seoul Nat'l Univ. Hospital
    Seongnam-si, Seongnam, Korea, Republic of
  • Ewha Womans University Mokdong Hospital
    Seoul, Korea, Republic of
  • Gangnam Sacred Heart Hospital
    Seoul, Korea, Republic of
  • Kyung Hee Univ Hospital
    Seoul, Korea, Republic of
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Apr 2019 and a completion of Jun 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2014
First posted
Mar 12, 2014
Start
Dec 2013
Primary completionActual
Apr 2019
CompletionActual
Jun 2019
Last update
Jul 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02084693
Lead sponsor
Zimmer Biomet
Responsible party
Sponsor
First posted
Mar 12, 2014
Start date
Dec 2013
Primary completion
Apr 2019
Completion
Jun 2019
Last update
Jul 5, 2019

Study contacts

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
Yong Girl Rhee, Ph.D.
principal investigator · Kyung Hee Univ. Hospital
Kyu Chul Noh, Ph.D.
principal investigator · Gangnam Sacred Heart Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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