Clinical trials: Complications; Arthroplasty
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.
Pain, Perioperative
Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement
The purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxiety and sleep disturbances.
- Trial name
- NCT00905437
- Testing
- Pregabalin
- Where
- 7 sites in India
- Volunteers
- 72 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Total Knee Arthroplasty (Postoperative Pain)
Phase 2B Study Assessing Pain Relief After Replacement of the Knee
The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty.
- Trial name
- SPARK2 (NCT06799845)
- Testing
- ATX101, bupivacaine hydrochloride
- Where
- 11 sites in United States
- Volunteers
- 226 people
- Sponsor
- Allay Therapeutics, Inc.
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
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
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
Pain, Postoperative
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores
This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with a Pain Catastrophizing…
- Trial name
- NCT03797612
- Testing
- Brivoligide Injection 660 mg/6 mL
- Where
- 2 sites in United States
- Sponsor
- Adynxx, Inc.
Osteoarthritis, Avascular Necrosis
PMCF Study of the CLS Brevius Stem With Kinectiv Technology
This study is a multi-center, prospective, non-controlled post-market surveillance study. The primary objective of this study is to confirm the safety and performance of the CLS Brevius stem with Kinectiv technology by obtaining…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Femoral Neck Fractures
- Trial name
- NCT03410940
- Testing
- CLS Brevius stem with Kinectiv technology
- Where
- 4 sites in Italy, Poland and 1 more
- Volunteers
- 223 people
- Sponsor
- Zimmer Biomet
Postoperative Pain
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative…
- Trial name
- NCT00403234
- Testing
- Buprenorphine transdermal patch
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Purdue Pharma LP
Postsurgical Pain
Study to Evaluate Safety/Efficacy of a Single Pre-Op 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 at two dose/volume levels.
- Trial name
- NCT02081703
- Testing
- AYX1 Injection 660 mg / 6 mL, AYX1 Injection 1100 mg / 10 mL
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Adynxx, Inc.
Postoperative Pain
Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty
This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
- Trial name
- NCT00818493
- Testing
- Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride), Percocet (oxycodone and acetaminophen)
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- QRxPharma Inc.
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
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
Postsurgical Pain
Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an elective TKA.
- Trial name
- NCT03731364
- Testing
- CA-008
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Concentric Analgesics
Complications; Arthroplasty
In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal…
- Trial name
- NCT01882751
- Testing
- Conformis CR Total Knee Replacement, Off the Shelf
- Where
- 2 sites in United States
- Volunteers
- 66 people
- Sponsor
- Restor3D
Postoperative Pain
Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty
Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty
- Trial name
- TKA (NCT00485693)
- Testing
- Bupivacaine HCl, SKY0402
- Where
- 9 sites in United States, Czechia
- Volunteers
- 138 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Postoperative Complications, Memory Disorders
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic…
- Trial name
- NCT00736125
- Testing
- pulsatile saline lavage, carbon dioxide lavage
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Kinamed Incorporated
Acute Pain
Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the…
- Trial name
- DAVID-art (NCT01902134)
- Testing
- Tramadol-single dose, Dexketoprofen-single dose, Dexketoprofen/Tramadol-single dose
- Where
- 37 sites in Czechia, Germany and 8 more
- Volunteers
- 641 people
- Sponsor
- Menarini Group
Arthroplasty Complications, Infection
Persona Revision Knee System Outcomes
The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment.
- Conditions
- Arthroplasty Complications, Infection, Knee Disease, Knee Osteoarthritis
- Trial name
- NCT04821154
- Testing
- Persona Revision Knee System
- Where
- 16 sites in United States
- Volunteers
- 380 people
- Sponsor
- Zimmer Biomet
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.