Clinical trials: Total Shoulder Arthroplasty
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
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
Shoulder Injuries, Patient Satisfaction
Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty
Reverse total shoulder arthroplasty (RTSA) can reliably restore active forward elevation, abduction, and external rotation, which are often lost in patients with massive rotator cuff tears.
- Conditions
- Shoulder Injuries, Patient Satisfaction, Internal Rotation Contracture-shoulder
- Trial name
- NCT05753904
- Testing
- Conjoint Tendon Resection
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2
Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?
To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral…
- Trial name
- DELPHI (NCT01737060)
- Testing
- Reverse total shoulder arthroplasty
- Where
- Norway
- Volunteers
- 124 people
- Sponsor
- Oslo University Hospital
Reverse Total Shoulder Arthroplasty, Physical Therapy
Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
This is a trial comparing self-directed rehabilitation using the Zimmer Biomet mymobility digital platform versus standard office-based physical therapy after reverse shoulder replacement.
- Trial name
- NCT05789784
- Testing
- mymobility Physical Therapy, Standard Office-based Physical Therapy
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- Campbell Clinic
Glenohumeral Osteoarthritis
Pyrocarbon Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis
This is a multi-center study assessing postoperative outcomes associated with hemiarthroplasty with pyrocarbon (hPYC) versus anatomic total shoulder arthroplasty (aTSA).
- Trial name
- NCT07226388
- Testing
- Hemiarthroplasty with pyrocarbon, Anatomic total shoulder arthroplasty
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Washington University School of Medicine
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
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
Arthritis
Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement
This is a case study to evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following autologous bone grafting around the prosthesis at the time of implant.
- Trial name
- NCT00670852
- Testing
- X-rays and CT scan
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Osteoarthritis of Glenohumeral Joint
Columbia Shoulder Study (CSS)
This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study are to establish the safety, effectiveness, and value of the prosthetic system, and to collect information from expert shoulder surgeons…
- Trial name
- CSS (NCT01488006)
- Testing
- Bigliani/Flatow Shoulder System
- Where
- United States
- Volunteers
- 207 people
- Sponsor
- Columbia University
The Primary Disease Process Being Studied is Shoulder OA and the Effect of an All Polyethelene Glenoid Component on Shoulder Arthroplasty
This is a 2 Year Follow up Clinical and Radiographic Analysis of a Novel All Polyethelene Glenoid Component in Standard Total Shoulder Arthroplasty.
Two hundred patients will be analyzed both clinically (via validated outcomes measures) and radiographically (via 2 sets of standard radiographs) to determine the survival and degree of bone in growth of a novel all polyethelene…
- Trial name
- NCT01313741
- Testing
- Shoulder arthroplasty with anchor peg glenoid
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Knoxville Orthopedic Clinic
Osteoarthritis
Closed Suction Drainage in Shoulder Arthroplasty
The purpose of this study is to determine the limited effectiveness of drains during Total Shoulder Arthroplasty. Drains are used during joint arthroplasty procedures to decrease infection rates, swelling,and the number of…
- Trial name
- NCT02767453
- Testing
- Wound drainage, Total Shoulder Arthroplasty
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Columbia University
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 Pain, Shoulder Osteoarthritis
Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis.
Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used in Europe for glenohumeral osteoarthritis since 2004.
- Conditions
- Shoulder Pain, Shoulder Osteoarthritis, Shoulder Arthritis
- Trial name
- NCT03877315
- Testing
- Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System., Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.
- Where
- Denmark
- Volunteers
- 78 people
- Sponsor
- Zealand University Hospital
Reverse Total Shoulder Arthroplasty
Outcomes Following Delta Xtend Reverse Shoulder System
To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse Shoulder Stystem.
- Trial name
- NCT02014350
- Testing
- DePuy Delta Xtend Reverse TSA
- Where
- United States
- Sponsor
- Rothman Institute Orthopaedics
Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty
Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the…
- Trial name
- NCT06316050
- Testing
- humeral retroversion
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Consorci Sanitari de Terrassa
Osteoarthritis
Cemented vs. Non-Cemented TSA for OA of the Shoulder
The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that uncemented fixation of the humerus will…
- Trial name
- NCT00158418
- Testing
- Cemented Humeral Stem, Uncemented Humeral Stem
- Where
- Canada
- Volunteers
- 160 people
- Sponsor
- Fowler Kennedy Sport Medicine Clinic
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
Shoulder Arthritis
Reverse Shoulder Replacement: Age 60 or Younger Outcomes
The purpose of this study is to assess the early outcomes following Reverse Shoulder Arthroplasty (RSA) in patients sixty years or younger for the purpose of characterizing these patients, evaluating their clinical outcomes and…
- Trial name
- NCT03148184
- Testing
- shoulder x-ray
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Washington University School of Medicine
Pain
Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 155 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia
- Trial name
- NCT02713230
- Testing
- bupivacaine liposome injectable suspension
- Where
- 20 sites in United States, Belgium and 1 more
- Volunteers
- 156 people
- Sponsor
- Pacira Pharmaceuticals, Inc