Clinical trials: Arthroplasty Complications
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, Rheumatoid Arthritis
Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Lower Limb Deformity
- Trial name
- GK9B (NCT02175576)
- Testing
- Vanguard XP Bicruciate Knee System, Vanguard CR Knee System
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Postoperative Pain
Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty
This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty
- Trial name
- NCT01055015
- Testing
- Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
- Where
- 11 sites in United States
- Volunteers
- 141 people
- Sponsor
- QRxPharma Inc.
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Osteoarthritis, Hip, Complications; Arthroplasty
Encore Revelation Hip Stem
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.
- Trial name
- NCT01514318
- Testing
- Revelation Hip Stem (Revelation)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Encore Medical, L.P.
Pain, Postoperative
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement.
- Trial name
- NCT00508495
- Testing
- Paracetamol (acetaminophen), Paracetamol 1% solution, 0.9% sodium chloride solution
- Where
- 8 sites in Hungary
- Volunteers
- 148 people
- Sponsor
- Baxter Healthcare Corporation
Rotator Cuff Injuries, Shoulder Pain
ASHCOM Shoulder System and Its Related Instruments
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy; Traumatic, Arthroplasty Complications
- Trial name
- NCT04258605
- Testing
- ASHCOM Shoulder System
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Zimmer Biomet
Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
- Trial name
- NCT07091773
- Testing
- OLIZ Photobiomodulation Device
- Volunteers
- 68 people
- Sponsor
- LTBIO Co., Ltd.
Total Knee Arthroplasty
NEUROCUPLE™ in TKA Patients to Enhance Pain Management
This is a randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE™ patch for pain reduction and opioid consumption following TKA.
- Trial name
- NCT06460350
- Testing
- NEUROCUPLE™ Patch
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- nCap Medical
Post-surgical Pain
Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty.
- Trial name
- NCT02807428
- Testing
- AYX1 Injection 660 mg/6 mL
- Where
- 9 sites in United States
- Volunteers
- 210 people
- Sponsor
- Adynxx, Inc.
Arthrodesis, Degenerative Arthritis
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.
- Conditions
- Arthrodesis, Degenerative Arthritis, Rheumatoid Arthritis, Complications; Arthroplasty, Mechanical
- Trial name
- NCT01366989
- Testing
- Radiographic evaluation of previously implanted patients
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Stryker Trauma and Extremities
Total Hip Arthroplasty, Survival, Prosthesis
Multicenter Mpact DM France
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.
- Trial name
- NCT05818891
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Medacta International SA
Pain, Postoperative
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.
- Trial name
- NCT01015235
- Testing
- KAI-1678, Ketorolac Tromethamine
- Where
- New Zealand
- Volunteers
- 90 people
- Sponsor
- KAI Pharmaceuticals
Survival, Prosthesis
Prevision® PMCF Study
Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results…
- Trial name
- NCT03510065
- Testing
- Prevision®
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Analgesia
Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.
- Trial name
- NCT03974932
- Testing
- HTX-011, Ibuprofen, Acetaminophen
- Where
- 6 sites in United States
- Volunteers
- 116 people
- Sponsor
- Heron Therapeutics
Total Knee Replacement, Total Knee Arthroplasty
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)).
- Conditions
- Total Knee Replacement, Total Knee Arthroplasty, Pain, Postoperative Pain
- Trial name
- NCT02468934
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- SPR Therapeutics, Inc.
Total Knee Replacement, Total Knee Arthroplasty
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
The purpose of this study is to determine if electrical stimulation (small levels of electricity) in addition to the standard of care can safely and effectively reduce pain following total knee replacement more than the standard…
- Conditions
- Total Knee Replacement, Total Knee Arthroplasty, Pain, Postoperative Pain
- Trial name
- NCT03286543
- Testing
- SPRINT Beta System
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- SPR Therapeutics, Inc.
Osteoarthritis, Rheumatoid Arthritis
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity
- Trial name
- NCT01542580
- Testing
- Vanguard SSK 360 with PS Bearing, Vanguard SSK 360 with PSC bearing, Vanguard DA 360
- Where
- 12 sites in United States, Belgium and 6 more
- Volunteers
- 255 people
- Sponsor
- Zimmer Biomet
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
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