Clinical trials: Shoulder Arthroplasty
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.
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
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
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
Shoulder Injuries
IO Vancomycin in TSA
The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty. Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic…
- Trial name
- NCT05831774
- Testing
- Intervention - Intraosseous (IO) administration of vancomycin, Control - Standard IV administration of vancomycin
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- The Methodist Hospital Research Institute
Osteoarthritis, Hip Arthropathy
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty.
- Conditions
- Osteoarthritis, Hip Arthropathy, Shoulder Arthropathy
- Trial name
- NCT01937559
- Testing
- Tranexamic acid (TXA), Normal saline
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- The Hawkins Foundation
Shoulder Arthroplasty
A Post-Market Clinical Evaluation of the ReUnion TSA System
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 4-7 sites.
- Trial name
- NCT03858517
- Testing
- ReUnion TSA System
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Stryker Trauma and Extremities
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
Opioid Use
Opioid Consumption and Disposal After Shoulder Arthroplasty
Opioid medications are widely used after many orthopedic procedures and are routinely prescribed after shoulder replacement surgery.
- Trial name
- NCT05525975
- Testing
- Educational materials
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Brendan M. Patterson
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
Surgical Wound, Shoulder Arthritis
Dermabond PRINEO for Total Shoulder Arthroplasty
This is a research study to find out whether wound closure (the process of closing the surgical wound after the procedure is complete) with Dermabond PRINEO Skin Closure System (PRINEO) will be faster and improve wound healing…
- Conditions
- Surgical Wound, Shoulder Arthritis, Surgical Incision
- Trial name
- NCT03860181
- Testing
- Subcuticular Sutures - Surgeon 1, Metal Staples - Surgeon 2, PRINEO - Surgeon 1
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Medical University of South Carolina
Arthropathy Shoulder
Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty
The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in…
- Trial name
- NCT03663283
- Testing
- Liposomal Bupivacaine, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- Mayo Clinic
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
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
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
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
Arthritis, Glenohumeral Osteoarthritis
3D MR Versus 3D CT for Glenohumeral Arthritis
This study aims to assess the efficacy of three-dimensional magnetic resonance (MR) compared to three-dimensional computed tomography (CT) imaging.
- Trial name
- NCT03379545
- Testing
- 3-dimensional (3D) magnetic resonance (MR) imaging, 3D computed tomography (CT) imaging
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- NYU Langone Health
Pain, Postoperative, Brachial Plexus Block
Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty
This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.
- Trial name
- NCT05005260
- Testing
- Bupivacaine HCl, Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Mayo Clinic
Joint Disease
Comprehensive Shoulder System Nano IDE
The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
- Trial name
- Nano (NCT01936259)
- Testing
- Mini Stem, Nano
- Where
- 12 sites in United States
- Volunteers
- 258 people
- Sponsor
- Zimmer Biomet
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