Clinical trials: SHOULDER ARTHROPLASTY
Anatomic Total Shoulder Arthroplasty
Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments
The proposed clinical study will enroll patients indicated for standard of care anatomic total shoulder arthroplasty. They will receive all pre operative testing, intra-operative care including all implants and post operative…
- Trial name
- IRI (NCT01801241)
- Testing
- Anatomic TSA using IRI Instrumentation, Anatomic Total Shoulder Arthroplasty
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- The Cleveland Clinic
Pain
Liposomal Bupivacaine in Total Shoulder Arthroplasty
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible.
- Trial name
- EXP-TSA (NCT02570022)
- Testing
- Liposomal bupivacaine, Inter-scalene nerve block, Ropivacaine
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Postoperative Pain, Total Shoulder Arthroplasty
Cohort 1 (TSA) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)
Cohort 1 (subjects undergoing total shoulder arthroplasty, TSA) of a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical…
- Conditions
- Postoperative Pain, Total Shoulder Arthroplasty, Multimodal Analgesia
- Trial name
- AMAZE (NCT06109415)
- Testing
- HTX-011, Bupivacaine Hydrochloride, MMA regimen
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Heron Therapeutics
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
Fracture of Shoulder and Upper Arm
Exparel for Postoperative Pain Management in Shoulder Surgery
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
- Trial name
- NCT02472314
- Testing
- 1.3% Liposomal Bupivacaine, 0.125% Bupivacaine
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Wayne State University
Osteoarthritis, Knee, Osteoarthritis, Hip
Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Shoulder
- Trial name
- NCT02197273
- Testing
- Liposomal bupivacaine, Standard of care analgesia
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- OhioHealth
Post-operative Pain, Total Shoulder Arthroplasty
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients…
- Conditions
- Post-operative Pain, Total Shoulder Arthroplasty, Osteoarthritis of the Shoulder, Pain Management
- Trial name
- NCT03887650
- Testing
- Liposomal Bupivicaine 1.3%, Bupivacaine 0.5%
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Hartford Hospital
Osteoarthritis, Posttraumatic Arthrosis
Sidus Stem-Free Shoulder IDE Study
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
- Trial name
- NCT01878253
- Testing
- Sidus Stem-Free Total Shoulder Arthroplasty System
- Where
- 11 sites in United States, Canada
- Volunteers
- 95 people
- Sponsor
- Zimmer Biomet
Acute Pain
Liposome Bupivacaine Interscalene Total Shoulder
This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing…
- Trial name
- NCT03587636
- Testing
- liposome bupivacaine, Bupivacaine
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Rotator Cuff Injuries, Shoulder Pain
Anaverse™ Glenoid System and Its Instrumentation
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy, Arthroplasty Complications
- Trial name
- NCT05215600
- Testing
- Anaverse Shoulder System
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Zimmer Biomet
Osteoarthritis
Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
The purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to…
- Trial name
- NCT03115177
- Testing
- Doxycycline, Cefazolin
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Rush University Medical Center
Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions
Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond
The objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures.
- Trial name
- NCT03899753
- Testing
- 2-Octyl Cyanoacrylate and Mesh, 2-Octyl Cyanoacrylate
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Shoulder Arthroplasty
A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites.
- Trial name
- NCT03880955
- Testing
- ReUnion RSA System
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- Stryker Trauma and Extremities
Osteoarthritis, Arthropathy
Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements.
- Conditions
- Osteoarthritis, Arthropathy, Shoulder Pain, Closed Fracture Proximal Humerus, Four Part
- Trial name
- NCT02762071
- Testing
- Liposomal bupivacaine, Interscalene Nerve Block
- Where
- 2 sites in United States
- Volunteers
- 108 people
- Sponsor
- Johns Hopkins University
Total Shoulder Arthroplasty, Shoulder Osteoarthritis
Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone
Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia…
- Trial name
- NCT03969875
- Testing
- Interscalene catheter, Liposomal bupivacaine, Dexamethasone
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Shoulder Joint Disease, Complications; Arthroplasty
Tranexamic Acid in Reverse Total Shoulder Arthroplasty
To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo…
- Conditions
- Shoulder Joint Disease, Complications; Arthroplasty, Intraoperative Complications, Blood Loss, Surgical
- Trial name
- TXA (NCT02043132)
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Corewell Health East
Anatomic Total Shoulder Arthroplasty
Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty
Glenoid component loosening is the most common complication of total shoulder arthroplasty. Loosening is associated with malposition of the implant as well as the quality of the glenoid bone.
- Trial name
- RTI (NCT01905241)
- Testing
- Anatomic TSA using RTI, Anatomic Total Shoulder Arthroplasty
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Cleveland Clinic
Rotator Cuff
Safety of Treatment of Shoulder Repair
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
- Trial name
- HEALICOIL_KNTL (NCT04552119)
- Testing
- HEALICOIL Knotless PEEK, HEALICOIL Knotless REGENESORB
- Where
- 5 sites in United States
- Volunteers
- 138 people
- Sponsor
- Smith & Nephew, Inc.
Primary Anatomic or Reverse Total Shoulder Arthroplasty
Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast
Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery.
- Trial name
- NCT04609306
- Testing
- H2O2 application to incision
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Florida
Mastectomy, Upper Limb Amputation Below Elbow
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this…
- Conditions
- Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee
- Trial name
- NCT03578237
- Testing
- Cryoneurolysis (active)
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of California, San Diego