A Clinical Investigation of the Comprehensive®, BioModula... | NCT00699270

Studies
A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

NCT00699270

Sponsor

Biomet Orthopedics, LLC

Status

Withdrawn

Last Update Posted

Jun 21, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Humeral Fractures

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business need changed.

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 13, 2008

First Posted Date

Jun 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2017

Last Update Posted Date

Jun 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biomet Humeral Stems		Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UCLA End Result Score		3 months, 6 months, 1 year, 3 years, 5 years
X-rays		3 month, 1 year, 3 years, 5 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of revisions and removals		Any time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid Arthritis
Correction of functional deformity

Exclusion Criteria:

Absolute contraindications:

- Infection, Sepsis, and Osteomyelitis

Relative contraindications:

Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
Osteoporosis
Metabolic disorders which may impair bone function
Osteomalacia
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients that have already made the decision to undergo shoulder replacement surgery and will receive a Biomet humeral stem.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Kenneth J Beres, MD	Clinical Research, Biomet Orthopedics, LLC	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D010020	Osteonecrosis
D001172	Arthritis, Rheumatoid
D006810	Humeral Fractures

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided