Sidus Stem-Free Shoulder IDE Study

NCT01878253 | Completed Results FDA Device

• 2 other identifiers: CIU2012-12EG130026
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 11

Brief Summary

The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.

Conditions

Osteoarthritis; Posttraumatic Arthrosis; Rheumatoid Arthritis

Keywords

Total Shoulder Arthoplasty

Outcome Measures

Primary Outcomes (4)

• Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire

  Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.

  Two years

• Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment

  absence of radiographic evidence of pending failure of the humeral components, assessed at 2 years which may include the following: * implant fracture * progressive implant migration or subsidence ≥ 5 mm

  Two years

• The Number of Device Related Serious Adverse Events.

  This outcome will measure the frequency of device related serious adverse events.

  Two years

• Survivorship

  The Kaplan-Meier method was used for this study. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 2 years post-operative (whichever came first).

  Up to Two years

Secondary Outcomes (2)

• ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire

  6 weeks, 6 months, and 1 year

• SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire.

  Pre-Op, 6 weeks, 6 months, 1 year and 2 years

Study Arms (1)

Investigational

EXPERIMENTAL

This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.

Device: Sidus Stem-Free Total Shoulder Arthroplasty System

Interventions

Sidus Stem-Free Total Shoulder Arthroplasty System DEVICE

Investigational

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 22 years of age or older.
• Patient is skeletally mature.
• Patient must have signed the IRB/EC approved informed consent.
• Patient is a candidate for a total shoulder arthroplasty (replacement of humeral head and glenoid).
• Patient has a diagnosis of primary osteoarthritis of the shoulder of grade III or higher.
• Patient has experienced symptoms of shoulder pain and/or loss of function for at least 6 months and has a maximum ASES score of 40.
• Patient has no findings to indicate an etiology of acute trauma, infection, avascular necrosis or inflammatory arthropathy of the operative shoulder.
• Patient has undergone no previous reconstructive shoulder surgery. Acceptable previous shoulder surgeries include arthroscopy, soft tissue repair, or pinning/screw fixation due to a historic fracture.
• Patient is willing and able to comply with the required post-operative therapy as defined in the protocol.
• Patient is willing and able to comply with the required follow-up schedule as defined in the protocol.

You may not qualify if:

• Patient is a prisoner.
• Patient is a known current alcohol or drug abuser.
• Patient has a psychiatric illness or cognitive deficit that precluded informed consent.
• Patient has a chronic renal impairment or failure.
• Patient sensitivity to implant materials.
• Patient has a vascular insufficiency due to large or small vessel disease which could inhibit postoperative healing.
• Local rash or skin infection around the intended operative site.
• Patients with ongoing Worker's Compensation or third party liability claims related to the operative shoulder.
• Pre-existing contra-lateral shoulder replacement less than 6 months ago.
• Patient who will require a contra-lateral shoulder replacement less than 6 months from the current planned shoulder replacement.
• Patient has evidence of major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, or previous shoulder surgery (other than arthroscopy, soft tissue repair, or pinning/screw fixation due to historic fracture).
• Patient has significant muscle paralysis.
• Patient has Charcot arthropathy.
• Patient has metaphyseal bony defects at the bone/implant interface which could inhibit prosthesis fixation.
• Patient has a preoperative computed tomography scans or other radiographic images of the shoulder that showed insufficient glenoid or humeral bone stock to allow for implantation of the prosthesis.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (11)

Stanford University

Redwood City, California, 94063, United States

Location

University of California San Francisco - Orthopaedics Institute

San Francisco, California, 94158, United States

Location

St. Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Norton Orthopaedic & Sports Medicine

Louisville, Kentucky, 40241, United States

Location

MedStar Health

Baltimore, Maryland, 21218, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

University of Calgary Sports Medicine Clinic

Calgary, Alberta, T2N 1N4, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

St. Joseph's Health Care London - Hand and Upper Limb Centre

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Clinical Operation Director
• Organization: Zimmer Biomet Inc

Bill.Bourdeau@zimmerbiomet.com

574-371-9823

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: June 14, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 15, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-07

Locations

CA (3); US (8)