Osteoarthritis of Glenohumeral JointCSSNCT01488006
Columbia Shoulder Study (CSS)
An observational study of Osteoarthritis of Glenohumeral Joint, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of Glenohumeral Joint
- What is being tested?
- Bigliani/Flatow Shoulder System
- Type of treatment
- Medical device
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Nov 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis of Glenohumeral Joint
- Being tested
- Bigliani/Flatow Shoulder System
- Keywords
- Primary Glenohumeral Osteoarthritis, Total shoulder arthroplasty, Total shoulder replacement, Osteoarthritis, Multicenter study
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bigliani/Flatow Shoulder SystemDevice
Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Bigliani/Flatow Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Radiographic Measurements of Standard Glenohumeral Relationships
Measured: Up to 16 weeks prior to date of surgery
Change in Post-operative Radiographic Measurements of Prosthetic Relationships (Anteroposterior and Axillary x-rays)
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.
Measured: Up to 5 years postoperatively
Change in Radiographic Analysis for Lucent Lines and Prosthesis Loosening
glenoid and humeral component lucency
Measured: Up to 5 year postoperatively
Secondary outcomes (6)
Change in Score on Short-Form 36 (SF-36)
Mental component score, physical component score, mental health, physical function, role emotional, role physical, social function, vitality, bodily pain and general health
Measured: Up to 5 years postoperatively.
Change in Score on EuroQOL (EQ-5D)
Total index, visual analog scale, mobility, anxiety/depression, pain/discomfort, self-care, and usual activities.
Measured: Up to 5 years postoperatively.
Change in ASES (American Shoulder and Elbow Surgeons) Score
Measured: Up to 5 years postoperatively.
Change in Total Score on Simple Shoulder Test (SST)
Total score.
Measured: Up to 5 years postoperatively.
Change in Constant Score
Measured: Up to 5 years postoperatively.
Change in Range of Motion
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
Measured: Up to 5 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startApr 2001
- Primary completionOct 2009
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of Glenohumeral JointStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- William N Levine, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488006
- Sponsor's protocol ID
- AAAA5360
- Acronym
- CSS
- Status last verified
- Jul 2015
- First submitted
- 29 Nov 2011
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5- Year Follow-up in Total Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT01488006
- Acronym / sponsor ID
- CSS / AAAA5360
- Conditions
- Osteoarthritis of Glenohumeral Joint
- Keywords
- Primary Glenohumeral Osteoarthritis, Total shoulder arthroplasty, Total shoulder replacement, Osteoarthritis, Multicenter study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Apr 2001
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Dec 2011 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bigliani/Flatow Shoulder System | – | Device: Bigliani/Flatow Shoulder SystemOther 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Bigliani/Flatow Shoulder SystemPrimary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis | Device | Bigliani/Flatow Shoulder System |
Primary outcome
Preoperative Radiographic Measurements of Standard Glenohumeral Relationships
Time frame: 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.
Change in Radiographic Analysis for Lucent Lines and Prosthesis Loosening
Time frame: Up to 5 year postoperatively
glenoid and humeral component lucency
6 secondary outcomes
Change in Score on Short-Form 36 (SF-36)
Time frame: Up to 5 years postoperatively.
Change in Score on EuroQOL (EQ-5D)
Time frame: Up to 5 years postoperatively.
Change in ASES (American Shoulder and Elbow Surgeons) Score
Time frame: Up to 5 years postoperatively.
Change in Total Score on Simple Shoulder Test (SST)
Time frame: Up to 5 years postoperatively.
Change in Constant Score
Time frame: Up to 5 years postoperatively.
Change in Range of Motion
Time frame: Up to 5 years postoperatively.
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 9 Jul 2015.
Related trials for Osteoarthritis of Glenohumeral Joint
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Not yet recruiting
Clinical Evaluation of TrHCROSS® for Different Joints
Joint Osteoarthritis, Knee Osteoarthristis
RecruitingPhase 4
PRP for Glenohumeral Osteoarthritis
Shoulder Osteoarthritis
Active, not recruitingObservational study
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
Arthroplasty, Replacement, Shoulder, Glenoid Cavity
RecruitingObservational study
Exactech Shoulder Post Market Clinical Follow-up Study
Osteo Arthritis Shoulders, Osteonecrosis
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.
William N Levine, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of Glenohumeral Joint, run by Columbia University at 1 site in United States.
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 5 inclusion and 6 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Preoperative Radiographic Measurements of Standard Glenohumeral Relationships (time frame: Up to 16 weeks prior to date of surgery). The study lists 3 primary outcomes in all. 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 9 Jul 2015.