Clinical trials: Total Shoulder Arthroplasty
Osteoarthritis, Rotator Cuff Tear Arthropathy
Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty
The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is…
- Conditions
- Osteoarthritis, Rotator Cuff Tear Arthropathy, Reverse Total Shoulder Arthroplasty, Scapular Notching
- Trial name
- NCT02052466
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Eric Ricchetti
Surgery, Surgical Site Infection
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after…
- Conditions
- Surgery, Surgical Site Infection, Cutibacterium Acnes, Prosthetic-joint Infection
- Trial name
- NCT05919888
- Testing
- Povidone-Iodine, SURGX Wound Gel
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- St. Louis University
Glenohumeral Arthritis, Total Shoulder Arthroplasty
Pain Management After Total Shoulder Arthroplasty
The purpose of the study is to determine if pain management after total shoulder arthroplasty is more efficacious with ultrasound guided, continuous Interscalene block or with local tissue infiltration with liposomal bupivacaine.
- Trial name
- NCT03219983
- Testing
- Ropivacaine, liposomal bupivacaine
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- The Christ Hospital
Shoulder Arthritis
A Study Comparing Shoulder Replacement Techniques For Patients With Shoulder Arthritis And An Intact Rotator Cuff
The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder…
- Trial name
- SOAR (NCT07584356)
- Testing
- aTSA, rTSA
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Mayo Clinic
Arthroplasty, Replacement, Shoulder
Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)
The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical…
- Trial name
- NCT04861714
- Testing
- Regeneten, Standard repair
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Ohio State University
Shoulder Fractures, Shoulder Arthritis Osteoarthritis
Zimmer Biomet Shoulder Arthroplasty PMCF Study
This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in…
- Conditions
- Shoulder Fractures, Shoulder Arthritis Osteoarthritis, Shoulder Injury, Shoulder Pain
- Trial name
- NCT06920459
- Testing
- Alliance™ Glenoid
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Total Shoulder Arthroplasty
Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections
The purpose of this study is to determine the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder.
- Trial name
- NCT02143245
- Testing
- Synovial Biopsy, Open Tissue Biopsy
- Where
- 4 sites in Canada
- Volunteers
- 118 people
- Sponsor
- Ottawa Hospital Research Institute
Shoulder Arthritis
Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
Total shoulder arthroplasty is an effective procedure to improve patients function and to relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this procedure is implanting the glenoid component.
- Trial name
- PITSA (NCT03839758)
- Testing
- TSA standard, RTSA standard, TSA Blueprint
- Where
- Canada
- Volunteers
- 112 people
- Sponsor
- Université de Montréal
Total Shoulder Arthroplasty
Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study
Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase.
- Trial name
- GSSNRSA (NCT03730597)
- Testing
- reverse shoulder arthroplasty
- Volunteers
- 95 people
- Sponsor
- Hospital del Mar
Total Shoulder Arthroplasty
Interscalene Dynamometer Pilot Study
Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain. Commonly, patients receive general anesthesia with interscalene block (injection of local anesthetic or numbing medicine near nerves in the…
- Trial name
- NCT01550952
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hospital for Special Surgery, New York
Pain, Postoperative
Analgesic Efficacy of Interscalene Nerve Block Versus Local Infiltration Analgesia Following Total Shoulder Arthroplasty
Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in severe postoperative pain, especially in the first 48 hours after surgery.
- Trial name
- NCT02876055
- Testing
- Single shot interscalene nerve block, Continuous interscalene nerve block, Local Infiltration Analgesia (LIA)
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Rotator Cuff Tear Arthropathy
Impact of Humeral Component Version on Outcomes Following RTSA
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder…
- Trial name
- NCT03111147
- Testing
- 0 degrees humeral component version, 30 degrees humeral component retroversion
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Corewell Health East
Osteoarthritis
Lesser Tuberosity Osteotomy for Subscapularis Repair
The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement.
- Trial name
- NCT02762903
- Testing
- TSA with tenotomy technique, TSA with lesser tuberosity osteotomy technique, Shoulder prosthesis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Shoulder Arthroplasty
Total Shoulder Arthroplasty Multi-Center Registry
The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.
- Trial name
- NCT03511586
- Where
- 27 sites in United States, Germany and 2 more
- Volunteers
- 2,500 people
- Sponsor
- Arthrex, Inc.
Total Shoulder Arthroplasty
Analgesia After Total Shoulder Arthroplasty
The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in the shoulder) for patients undergoing total…
- Trial name
- NCT01782872
- Testing
- Interscalene Block (ISB) - 0.375% Ropivacaine + additives, Interscalene Block (ISB) - 0.2% Ropivacaine + additives, Interscalene Block (ISB) - 0.1% Ropivacaine + additives
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Hospital for Special Surgery, New York
Arthroplasty, Replacement, Shoulder
Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
The aim of the study is to evaluate if intravenous steroid supplementation can provide advantages over routine analgesia protocols in terms of post-operative symptoms (pain and nausea), length of hospital stay, shoulder range of…
- Trial name
- NCT04507412
- Testing
- dexamethasone
- Where
- Switzerland
- Volunteers
- 74 people
- Sponsor
- Christian Candrian
Osteoarthritis
Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System
The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power.
- Trial name
- Epoca H vs T (NCT01288066)
- Testing
- Hemiarthroplasty, Total arthroplasty
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- AO Innovation Translation Center
Total Shoulder Arthroplasty
Exparel for Total Shoulder Arthroplasty
The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 72 hours after Total Shoulder Arthroplasty (TSA) compared to a pain pump.
- Trial name
- NCT04364867
- Testing
- Exparel, Pain Pump
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Norton Healthcare
Periprosthetic Infection, Oral Antibiotics
Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI
Cutibacterium acnes (C. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. It is increasingly recognized as a pathogen, mainly in implant-related infections.
- Conditions
- Periprosthetic Infection, Oral Antibiotics, Revision Total Shoulder Arthroplasty
- Trial name
- NCT04636125
- Testing
- Doxycycline 100 MG Oral Tablet
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics
Osteoarthritis, Avascular Necrosis
A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Humeral Fractures
- Trial name
- NCT00699270
- Sponsor
- Biomet Orthopedics, LLC