Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Zimmer Biomet
- Enrollment
- 95
- Locations
- 11
- Primary Endpoint
- The Number of Device Related Serious Adverse Events.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Detailed Description
The primary objectives of this study are to evaluate the safety and efficacy (defined as follows) of the Sidus Stem-Free Shoulder System in unilateral primary total shoulder arthroplasty. Safety: Will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects (UADEs) in investigational subjects as well as analyzing survivorship using revision or intended revision as an endpoint. Efficacy: Will be determined by comparing the overall pain and functional performance, survivorship and radiographic success of investigational subjects with those subjects who received the control devices.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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.
- •Patient is currently receiving or has received within the last 3 months chronic systemic or inhaled steroids. This exclusion does not apply to those patients with occasional inhaler use due to seasonal allergies.
- •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.
Outcomes
Primary Outcomes
The Number of Device Related Serious Adverse Events.
Time Frame: Two years
This outcome will measure the frequency of device related serious adverse events.
Survivorship
Time Frame: Up to Two years
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).
Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment
Time Frame: Two years
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
Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Time Frame: Two years
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.
Secondary Outcomes
- 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)