Clinical trial NCT02084693: COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate
Official title: Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear Arthropathy
Osteoporosis
Osteomalacia
Joint; Destruction, Sacroiliac
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

Eligibility criteria: 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:

* 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:

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.

Primary outcomes:
measure: Survivorship
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Events (including dislocation)
timeFrame: 3 year
measure: Constant-Murley Shoulder Score
timeFrame: 3 year
measure: Radiographic Evaluation (Plain X-ray and CT)
timeFrame: 3 year
measure: Scapular Notching
timeFrame: 3 year
measure: Constant-Murley Shoulder Score
timeFrame: 1 year
measure: Constant-Murley Shoulder Score
timeFrame: 6 Months
measure: Radiographic Evaluation
timeFrame: 1 year
measure: Radiographic Evaluation
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bunndang Seoul Nat'l Univ. Hospital
state: Seongnam
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee Univ Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Bundang Seoul Nat'l University Hospital
name: Joo Han Oh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Mokdong Hospital
name: Sang Jin Shin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Jae Chul Yoo, Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee Univ. Hospital
name: Yong Girl Rhee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangnam Sacred Heart Hospital
name: Kyu Chul Noh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: