Clinical trials: Complications; Arthroplasty
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
Post-Operative Pain
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Postoperative Pain Following Total Hip Arthroplasty.
The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, and placebo-controlled study.
- Trial name
- NCT03347266
- Testing
- VVZ-149 injections
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Vivozon, Inc.
Osteoarthritis, Avascular Necrosis
Arcos Revision Stem: Evaluation of Clinical Performance
The primary purpose of this study is to evaluate the clinical performance of the Arcos Revision Stem system, determine the stability of the implants, and evaluate any relationship between Paprosky bone defect level and the…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Deformity
- Trial name
- NCT01820611
- Testing
- Arcos Revision Stem System
- Where
- 5 sites in Finland, Spain and 2 more
- Volunteers
- 74 people
- Sponsor
- Zimmer Biomet
Osteo Arthritis Shoulders
Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.
- Trial name
- NCT03782675
- Testing
- Control, Air Barrier System
- Volunteers
- 40 people
- Sponsor
- Nimbic Systems, LLC
Analgesia
Safety of F14 Following Total Knee Replacement
Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia
- Trial name
- NCT04860635
- Testing
- F14 (sustained release celecoxib)
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Arthritis Innovation Corporation
Postsurgical Pain
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis.
- Trial name
- MP-TKA (NCT06202989)
- Testing
- Multiprofen-CC™ plus standard treatment
- Where
- Canada
- Volunteers
- 306 people
- Sponsor
- KAZM Pharmaceuticals Inc.
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
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
Wound Heal
Performance, Safety and Efficacy of PICO Device.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the…
- Trial name
- NCT03698968
- Testing
- Negative Pressure Wound Therapy
- Where
- 11 sites in Switzerland, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Postoperative Pain
Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral…
- Trial name
- NCT01683071
- Testing
- EXPAREL 67 mg, EXPAREL 133 mg, EXPAREL 266 mg
- Where
- 30 sites in United States
- Volunteers
- 297 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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.
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
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
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants…
- Conditions
- Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections, Joint Instability
- Trial name
- NCT07653295
- Testing
- Tıpmed™ Revision Hip Prosthesis System
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 35 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
Pain, Postoperative
Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty
The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA).
- Trial name
- NCT05017701
- Testing
- Bridge device
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Masimo Corporation
Postoperative Pain
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and…
- Trial name
- NCT03015532
- Testing
- HTX-011, Bupivicaine HCl, Ropivacaine
- Where
- 24 sites in United States
- Volunteers
- 285 people
- Sponsor
- Heron Therapeutics
Pain, Postoperative
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.
- Trial name
- NCT03434275
- Testing
- N1539
- Where
- 6 sites in United States
- Volunteers
- 194 people
- Sponsor
- Baudax Bio
Arthroplasty Complications, Osteo Arthritis Shoulders
Comprehensive SRS Regenerex Tissue Attachment
The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb…
- Trial name
- NCT06615739
- Testing
- Regenerex Tissue Attachment Augments
- Where
- United States
- Volunteers
- 22 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