Columbia Shoulder Study (CSS) (CSS)

July 7, 2015 updated by: Columbia University

5- Year Follow-up in Total Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: A Prospective Multicenter Study

This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study are to establish the safety, effectiveness, and value of the prosthetic system, and to collect information from expert shoulder surgeons as to features of the implants, instruments, and techniques which may be further improved. In this study, the investigators hypothesize that this prosthetic device will significantly improve long-term patient-based outcomes, functional status and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Over the last two decades, total shoulder joint replacement - or arthroplasty - has become a commonly performed procedure for the treatment of painful arthritis of the shoulder, and numerous studies have demonstrated its success. During this time, much has been learned about the efficacy, as well as the complications, of the procedure, and since its introduction in the 1950's, shoulder arthroplasty has undergone an evolution in design. The value of such innovations has not yet been determined and will depend on the results of long term follow-up studies. The purpose of this study is to provide follow-up information and design modification directives.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be recruited when the decision to undergo shoulder arthroplasty is made. The surgeon will confirm that the subject is appropriate for inclusion in the study. The surgeon will confirm that the subject is appropriate for inclusion in the study.

Description

Inclusion Criteria:

  • Patient must be 18 years of age or over.
  • Patient must have signed The Informed Consent and Release of Medical Information forms.
  • The patient can be a man, postmenopausal woman, or a woman who is likely to become pregnant but is using adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraception or a combination of a condom and spermicide).
  • Patient needs a total shoulder arthroplasty (humeral head and glenoid).
  • Patient has a diagnosis of primary osteoarthritis.

Exclusion Criteria:

  • Obstacles, which pose an inordinately high surgical risk, in the judgment of the certified surgeon.
  • Class IV or higher anesthetic risk.
  • Patient has a recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair the compliance with the study protocol.
  • Patient has had a shoulder fracture.
  • Patient had previous shoulder surgeries with the exception of an arthroscopic debridement procedure.
  • The patients has a massive rotator cuff tear (rupture >3 cm or total cicatrisation) demonstrated at time of the surgery that precludes the total shoulder replacement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Bigliani/Flatow Shoulder System
Other than the Bigliani/Flatow device, there will be no difference in treatment between those patients undergoing arthroplasty with the Bigliani / Flatow prosthesis and those who previously received other prosthesis. APatients who decide to participate in the study will complete various forms prior to surgery (The Informed Consent, Contact Information Form, Demographics Module, and standard outcomes forms such as American Shoulder and Elbow Surgeon Score form, Constant's Score form, and the Simple Shoulder Test, EuroQOL and SF-36). The patient will also complete forms postoperatively at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year intervals (American Shoulder and Elbow Surgeon Score form, Constant's Score form, Simple Shoulder Test, EuroQOL and SF-36).
Device: Bigliani/Flatow Shoulder System
Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preoperative Radiographic Measurements of Standard Glenohumeral Relationships
Time Frame: Up to 16 weeks prior to date of surgery
Up to 16 weeks prior to date of surgery
Change in Post-operative Radiographic Measurements of Prosthetic Relationships (Anteroposterior and Axillary x-rays)
Time Frame: Up to 5 years postoperatively
Measurements include acromiohumeral interval, head to tuberosity distance, coracoid to glenohumeral joint distance, coracoid to tuberosity distance, humeral stem position (valgus/varus), humeral congruity and subluxation, glenoid comp version.
Up to 5 years postoperatively
Change in Radiographic Analysis for Lucent Lines and Prosthesis Loosening
Time Frame: Up to 5 year postoperatively
glenoid and humeral component lucency
Up to 5 year postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Score on Short-Form 36 (SF-36)
Time Frame: Up to 5 years postoperatively.
Mental component score, physical component score, mental health, physical function, role emotional, role physical, social function, vitality, bodily pain and general health
Up to 5 years postoperatively.
Change in Score on EuroQOL (EQ-5D)
Time Frame: Up to 5 years postoperatively.
Total index, visual analog scale, mobility, anxiety/depression, pain/discomfort, self-care, and usual activities.
Up to 5 years postoperatively.
Change in ASES (American Shoulder and Elbow Surgeons) Score
Time Frame: Up to 5 years postoperatively.
Up to 5 years postoperatively.
Change in Total Score on Simple Shoulder Test (SST)
Time Frame: Up to 5 years postoperatively.
Total score.
Up to 5 years postoperatively.
Change in Constant Score
Time Frame: Up to 5 years postoperatively.
Up to 5 years postoperatively.
Change in Range of Motion
Time Frame: Up to 5 years postoperatively.
Active and passive external rotation at 90 degrees and at side, active and passive forward elevation, active and passive abduction, active and passive internal rotation
Up to 5 years postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William N Levine, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAA5360

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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