Clinical trials: Arthroplasty, Replacement, Shoulder
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease
- Trial name
- NCT04003311
- Testing
- Comprehensive Primary Micro Stem, Comprehensive Anatomic Versa-Dial Titanium Humeral Head
- Where
- 4 sites in United States
- Volunteers
- 146 people
- Sponsor
- Zimmer Biomet
Total Shoulder Arthroplasty
Patient Specific Instruments Versus Standard Surgical Instruments
Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
- Trial name
- TIOSO-GPS (NCT01430468)
- Testing
- Glenoid Positioning System
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- The Cleveland Clinic
Postoperative Pain, Acute, Shoulder Pain
Evaluating Intercostobrachial Nerve Block's Effect on Pain Control After Shoulder Replacement
Interscalene blocks are frequently performed to decrease postoperative pain after shoulder surgeries and are considered the gold standard for pain control after this type of surgery.
- Trial name
- NCT06042608
- Testing
- intercostobrachial nerve block
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Arthroplasty, Replacement, Shoulder
Testosterone Levels and Cutibacterium
Phase 1: In 51 patients undergoing shoulder arthroplasties, total serum testosterone, free testosterone and sex hormone binding globulin levels obtained in the clinic before surgery were correlated with the levels of…
- Trial name
- NCT05030220
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- University of Washington
Total Shoulder Arthroplasty, Shoulder Infection
Surgiphor Us in TSA
Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis.
- Conditions
- Total Shoulder Arthroplasty, Shoulder Infection, Povidone Iodine
- Trial name
- NCT06601803
- Testing
- sterile saline solution, Surgiphor, Sample Collection
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics
Osteoarthritis of Shoulder
Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty
The purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.
- Trial name
- NCT03921944
- Testing
- CT scan of the shoulders
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Milton S. Hershey Medical Center
Osteoarthritis
Global® AP™ Total Shoulder Arthroplasty
This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.
- Trial name
- NCT00719771
- Testing
- Global® AP™ Total shoulder arthroplasty
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- DePuy Orthopaedics
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
Pain Management, Postoperative Pain
PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation
This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid…
- Trial name
- NCT07765238
- Testing
- PCDD Generation 1 system
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Yale University
Shoulder Osteoarthritis, Cuff Tear Arthropathy
Local Infiltration Analgesia Vs. Interscalene Block in Total Shoulder Arthorplasty
Pain management following total shoulder arthroplasty is an important factor in determining patient outcomes and satisfaction. Interscalene brachial plexus blockade has been used successfully to minimize pain in the acute…
- Conditions
- Shoulder Osteoarthritis, Cuff Tear Arthropathy, Massive Rotator Cuff Tear
- Trial name
- NCT04415931
- Testing
- Local infiltration analgesia, Interscalene block
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- University of Missouri-Columbia
Rotator Cuff Arthropathy
Focus on the Humeral Component Following Reverse Shoulder Arthroplasty
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to…
- Trial name
- RSA (NCT04809077)
- Testing
- Reverse total shoulder replacement
- Where
- Belgium
- Volunteers
- 123 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Arthritis
Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.
We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting.
- Trial name
- Glenoid (NCT02136251)
- Sponsor
- University of Nebraska
Osteo Arthritis Shoulders, Traumatic Arthritis
Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder System 2.5 when used for…
- Conditions
- Osteo Arthritis Shoulders, Traumatic Arthritis, Rheumatoid Arthritis
- Trial name
- NCT03250767
- Testing
- Integra Titan Modular Shoulder System 2.5
- Where
- 7 sites in United States
- Volunteers
- 58 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis of the Shoulder, Avascular Necrosis
Database Retrieval for the Comprehensive Shoulder
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products.
- Conditions
- Osteoarthritis of the Shoulder, Avascular Necrosis, Rheumatoid Arthritis, Prior Failed Revision
- Trial name
- NCT03409718
- Testing
- Biomet Comprehensive Shoulder System
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Shoulder Osteoarthritis
Fixed Inclination Humeral Cut
The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a…
- Trial name
- NCT03922763
- Testing
- Anatomical cut, Cutting guide
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Rothman Institute Orthopaedics
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, Rheumatoid Arthritis
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture
- Trial name
- NCT01480440
- Testing
- Trabecular Metal Reverse Shoulder System
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
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
Analgesia
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures.
- Trial name
- NCT05109312
- Testing
- Bupivacaine Hydrochloride, HTX-011, Luer lock applicator
- Where
- 7 sites in United States
- Volunteers
- 90 people
- Sponsor
- Heron Therapeutics