Phase 3 N=157 Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
Primary Generalized (Osteo)Arthritis · Post-traumatic Arthrosis of Other Joints, Upper Arm
Primary: Device Success Rate — 134 participants
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N/A N=261 Comprehensive Shoulder System Nano IDE
Joint Disease
Primary: American Shoulder and Elbow Surgeon's Score (ASES) — 92.20; 92.47 score on a scale
N/A N=34 Total Shoulder Arthroplasty Near-infrared Spectroscopy
Cerebral Ischemia
Primary: Number of Cerebral Desaturation Events — 0 Number of CDE Incidences
Phase 3 N=516 Reverse Shoulder Prosthesis Study
Rotator Cuff Arthropathy · Failed Total Shoulder · Failed Hemi-arthroplasty
Primary: American Shoulder and Elbow Surgeons Shoulder Score — 76; 62; 77 Units on a scale
N/A N=113 Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
Glenohumeral Joint Degeneration
Primary: Active Forward Elevation of the Shoulder — 146; 141; 143; 137 degrees of movement — p=.552
Phase 4 N=86 Opioid-Free Shoulder Arthroplasty
Opioid Use · Shoulder Osteoarthritis · Avascular Necrosis
Primary: Post Op Pain — 3.0; 2.0 score on a scale — p=.297
N/A N=20 Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty
Anatomic Total Shoulder Arthroplasty
Primary: Difference in Glenoid Component Placement (Inclination and Version) — 2.0; 5.3 degrees
N/A N=108 Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
TSA · Bruise · Pain, Postoperative
Primary: Numeric Rating Scale Pain Scores at Post-operative Day 14 — 1.6; 3.1 score on a scale
N/A N=87 Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty
Subscapularis Peel · Morselized Osteotomy
Primary: Subscapularis Strength — 4.4; 5.5 kg
Phase 4 N=57 Liposomal Bupivacaine in Total Shoulder Arthroplasty
Pain
Primary: Pain Levels — 4.8; 4.0; 4.7; 4.0 units on a scale — p=<0.05
Phase 4 N=102 Exparel for Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Primary: Pain Score in the 24 Hours After Surgery — 0.76; 3.37 score on a scale
N/A N=154 Anatomical Shoulder™ Inverse/Reverse Study
Cuff-tear Arthropathy
Primary: Functional Performance — 57.9 score on a scale
N/A N=52 Anatomical Shoulder™ Fracture PMCF Study
Fracture
Primary: Functional Performance — 57.7 score on a scale
Phase 4 N=80 Analgesia After Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Primary: Numeric Rating Scale (NRS) Pain Score With Movement — 4.5; 3.4; 4.2; 4.9 units on a scale
N/A N=95 Sidus Stem-Free Shoulder IDE Study
Osteoarthritis · Posttraumatic Arthrosis · Rheumatoid Arthritis
Primary: Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire — 89.4; 0.7 score on a scale
N/A N=85 Impact of Humeral Component Version on Outcomes Following RTSA
Rotator Cuff Tear Arthropathy
Primary: Postoperative External Range of Motion (ROM) — 35; 39 degrees
N/A N=56 Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments
Anatomic Total Shoulder Arthroplasty
Primary: Difference in Glenoid Component Placement (Inclination and Version) — 4.1; 3.1; 4.3; 4.0 degree
N/A N=90 Functional Outcomes Following Shoulder Surgery: A Prospective Database
Rotator Cuff Tear
Primary: Western Ontario Rotator Cuff Index — 72.9; 79.9 score on a scale (0-100)
N/A N=156 A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
Arthritis
Primary: Device Survival — 85.97 percentage of shoulders
N/A N=10 Interscalene Dynamometer Pilot Study
Total Shoulder Arthroplasty
Primary: Anterior Deltoid Strength — 77 percent
N/A N=19 Retrospective Encore Reverse Shoulder Prosthesis Study
Rotator Cuff Deficiency · Glenohumeral Arthritis
Primary: Survivorship of the Encore Reverse Shoulder Prosthesis — 13 participants
N/A N=44 Patient Specific Instruments Versus Standard Surgical Instruments
Total Shoulder Arthroplasty
Primary: Comparing Glenoid Component Positioning to Pre Operative Planning — 4.3; 6.9 Degrees — p=0.11
N/A N=32 Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty
Osteoarthritis · Rotator Cuff Tear Arthropathy · Reverse Total Shoulder Arthroplasty
Primary: Actual Versus Predicted Scapular Notching — 96.6 percentage of accurate predictions
N/A N=87 Multicenter Clinical Observation PROMOS®
Primary and Secondary Omarthrosis
Primary: Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components — 96.29 Percentage survivorship
N/A N=60 Lesser Tuberosity Osteotomy for Subscapularis Repair
Osteoarthritis
Primary: Number of Subjects With Radiologic Evidence of Anatomic Healing — 26; 27 Participants
N/A N=20 Orthopaedic Treatment Proximal Humeral Fractures
Proximal Humeral Fracture
Primary: Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma — 40.1; 51.8 units on a scale — p=<0.01
N/A N=157 Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty
Osteoarthritis · Avascular Necrosis · Traumatic Arthritis
Primary: Rate of Patient Success at 24 Months. — 120 Participants
N/A N=140 Opioid Consumption and Disposal After Shoulder Arthroplasty
Opioid Use
Primary: Difference in Proportion of Participants With > 10 Pills Left Unused. — 49; 47 Participants
N/A N=86 Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
Rotator Cuff Tear · Shoulder Impingement Syndrome
Primary: Western Ontario Rotator Cuff Index (WORC) — 80.5; 86.7 percentage of total score
N/A N=106 Multi Centre Study on TESS V2 Shoulder System
Osteoarthritis Shoulder · Fracture · Rheumatoid Arthritis
Primary: Constant Shoulder Score — 27.36; 63.5 score on a scale