Clinical trials: Arthroplasty, Replacement, Shoulder
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
Shoulder Arthroplasty
Shoulder Innovations Clinical Data Registry
The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).
- Trial name
- SICDR (NCT06754150)
- Where
- 10 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Shoulder Innovations
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
Shoulder Arthroplasty
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in…
- Trial name
- NCT03845894
- Testing
- Liposomal bupivacaine, Bupivacaine with adjuvants
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Shoulder Arthritis, Anesthesia, Local
Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial
Total shoulder arthroplasty (TSA) is a common and effective treatment for end-stage shoulder pathologies. Over the past 25 years, implant designs have evolved and the indications for joint replacement have expanded significantly…
- Conditions
- Shoulder Arthritis, Anesthesia, Local, Local Infiltration
- Trial name
- NCT05908851
- Testing
- 100 mL of 0.9% normal saline (57ml), 0.5% ropivacaine (40 ml), 10 mg morphine (10 mg/ml), 0.1 mg of epinephrine (0.1 mg/ml), and 30 mg of ketorolac (30 mg/ml)
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Arthropathy Shoulder
TXA in Revision Total Shoulder Arthroplasty
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group…
- Trial name
- NCT04650698
- Testing
- Tranexamic acid (TXA) injection
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- NYU Langone Health
Avascular Necrosis, Revision Surgery
Anatomical Shoulder Domelock System Study
The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event…
- Conditions
- Avascular Necrosis, Revision Surgery, Conditions Consequent to Earlier Operations, Arthritis, Rheumatoid
- Trial name
- NCT03312465
- Testing
- AS Domelock System
- Where
- 6 sites in Belgium, Germany and 2 more
- Volunteers
- 73 people
- Sponsor
- Zimmer Biomet
Postoperative Pain
Propofol Versus Sevoflurane on Acute Postoperative Pain
This study was performed to compare the acute postoperative pain intensity and opioid consumption after total shoulder arthroplasty between propofol-remifentanil and sevoflurane-remifentanil anesthesia.
- Trial name
- NCT04333992
- Testing
- propofol and remifentanil, sevoflurane and remifentanil
- Where
- South Korea
- Volunteers
- 48 people
- Sponsor
- Yeungnam University College of Medicine
Shoulder Arthropathy Associated With Other Conditions
Reverse Shoulder Replacement: Formal vs. Home Physiotherapy
The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear…
- Trial name
- NCT03430167
- Testing
- home therapy, formal therapy
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Washington University School of Medicine
Osteoarthritis of the Shoulder
Clinical Experience With the Zimmer Trabecular Metal (TM) Glenoid in Total Shoulder Arthroplasty
The objective of this randomized controlled study is to obtain outcomes data on the Zimmer TM glenoid component by analysis of standard scoring systems and radiographs in comparison to the cemented glenoid component.
- Trial name
- TMGlenoid (NCT01539122)
- Testing
- Zimmer TM Glenoid, Cemented Glenoid
- Where
- 6 sites in Canada
- Volunteers
- 104 people
- Sponsor
- Joint Preservation Centre of BC