Columbia Shoulder Study (CSS)

NCT01488006 | Completed

• 1 other identifier: AAAA5360
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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. In this study, the investigators hypothesize that this prosthetic device will significantly improve long-term patient-based outcomes, functional status and quality of life.

Conditions

Osteoarthritis of Glenohumeral Joint

Keywords

Primary Glenohumeral Osteoarthritis; Total shoulder arthroplasty; Total shoulder replacement; Osteoarthritis; Multicenter study

Outcome Measures

Primary Outcomes (3)

• Preoperative Radiographic Measurements of Standard Glenohumeral Relationships

  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.

  Up to 5 years postoperatively

• Change in Radiographic Analysis for Lucent Lines and Prosthesis Loosening

  glenoid and humeral component lucency

  Up to 5 year postoperatively

Secondary Outcomes (6)

• Change in Score on Short-Form 36 (SF-36)

  Up to 5 years postoperatively.

• Change in Score on EuroQOL (EQ-5D)

  Up to 5 years postoperatively.

• Change in ASES (American Shoulder and Elbow Surgeons) Score

  Up to 5 years postoperatively.

• Change in Total Score on Simple Shoulder Test (SST)

  Up to 5 years postoperatively.

• Change in Constant Score

  Up to 5 years postoperatively.

Study Arms (1)

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

Interventions

Bigliani/Flatow Shoulder System DEVICE

Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis

Bigliani/Flatow Shoulder System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• William N Levine, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 8, 2011
• Study Start: April 1, 2001
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2012
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

US (1)