Clinical trials: Total Knee Replacement Surgery
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
Post-Operative Pain
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery.
- Trial name
- NCT01539538
- Testing
- Sufentanil NanoTab PCA System/15 mcg, morphine IV PCA
- Where
- 16 sites in United States
- Volunteers
- 357 people
- Sponsor
- Talphera, Inc
Total Knee Replacement
Qualitative Interviews With Healthcare Professionals
PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement…
- Trial name
- NCT05597046
- Testing
- Interview
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Invibio Ltd
Surgical Wound
A Post-Market Clinical Investigation on Mepilex Border Post-Op
This is a retrospective, observational (non-interventional), single-arm, single-centre, post-market clinical investigation designed to verify clinical performance and safety of Mepilex Border Post-Op when used according to…
- Trial name
- ARCTIS (NCT04994145)
- Where
- Belgium
- Volunteers
- 560 people
- Sponsor
- Molnlycke Health Care AB
Arthroplasty, Replacement, Thromboembolism
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment
- Trial name
- NCT00847301
- Where
- 53 sites in Austria, France and 5 more
- Volunteers
- 472 people
- Sponsor
- Boehringer Ingelheim
Deep Vein Thrombosis, Fibrillation, Atrial
Odiparcil For The Prevention Of Venous Thromboembolism
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
- Conditions
- Deep Vein Thrombosis, Fibrillation, Atrial, Venous Thromboembolism, Pulmonary Embolism
- Trial name
- NCT00244725
- Testing
- Odiparcil, Warfarin, Coumadin
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 961 people
- Sponsor
- GlaxoSmithKline
Thromboembolism, Arthroplasty, Replacement, Hip
Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery
Open, prospective, uncontrolled, observational cohort study.
- Trial name
- NCT00967447
- Where
- 28 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Post-operation Pain
A Feasibility Dose-escalating Study of MDT-10013 for Acute Postoperative Pain Following Total Knee Arthroplasty
This is an open-label dose-escalating study to evaluate the tolerability and systemic exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary unilateral TKA.
- Trial name
- NCT02263222
- Testing
- MDT-10013
- Where
- 3 sites in United States
- Sponsor
- Medtronic Spinal and Biologics
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.
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.
Wound Closure
Symmetric on Total Knee Arthroplasty (TKA)
A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to…
- Trial name
- SFX (NCT03305887)
- Testing
- "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS, "STRATAFIX Spiral" sutures
- Where
- 7 sites in China
- Volunteers
- 184 people
- Sponsor
- Johnson & Johnson Medical, China
Knee Arthroplasty
Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients
The aim of this observational study is to assess whether patient reported pain levels correlate with a Pain Index derived from deviations in multivariate physiology biomarkers captured in real-world setting.
- Trial name
- ObservePAIN (NCT03789630)
- Testing
- Continuous physiology monitoring in ambulatory setting pre and post surgery
- Where
- Singapore
- Volunteers
- 55 people
- Sponsor
- Biofourmis Singapore Pte Ltd.
Neuromuscular Blockade, Arthroplasty, Replacement, Hip
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on…
- Conditions
- Neuromuscular Blockade, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Blood Coagulation
- Trial name
- NCT01422304
- Testing
- Sugammadex, neostigmine and glycopyrrolate or atropine
- Volunteers
- 1,198 people
- Sponsor
- Merck Sharp & Dohme LLC
Total Knee Replacement
Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement
The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.
- Trial name
- NCT01548040
- Testing
- Kneehab XP, Quadriceps TENS
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Theragen Inc.
Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement
This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery.
- Trial name
- NCT02491281
- Testing
- LNA043
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Arthroplasty, Replacement, Knee, Unicompartmental Knee Arthroplasty
Study to Evaluate Patient Outcomes and Safety and Effectiveness of Robotic Assisted Unicompartmental Knee Replacements Versus Conventional Unicompartmental Knee for Subjects With Primary Arthritis of the Knee Joint Involving One (UKA) Compartment (Medial or Lateral)
The overall aim of this trial is to compare functional and patient-reported outcomes and to assess the safety and effectiveness and long-term performance of the Smith+Nephew Robotic Systems for Unicompartmental Knee Replacements…
- Trial name
- NCT06036212
- Testing
- Robotic System, Conventional
- Where
- 5 sites in United Kingdom
- Sponsor
- Smith & Nephew, Inc.
Knee Replacement, Musculoskeletal
Intelligent Operating Room (InOR) for Orthopaedic Surgery
The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.
- Trial name
- InOR (NCT04167787)
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Digital Surgery Ltd.
Psychological Stress, Cardiopulmonary Bypass Surgery
CARINAE for Stress Relief in Perioperative Care
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure.
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement
- Trial name
- CARINAE (NCT05184725)
- Testing
- SaMD CARINAE
- Where
- 5 sites in Italy, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- Adhera Health, Inc.
Osteoarthritis, Arthritis
Bipolar Sealer Aquamantys Use in Total Knee Replacement
This study will compare the clinical outcomes for patients undergoing a total knee replacement using a bipolar sealer, the Aquamantys® System, as compared to standard electrocautery.
- Conditions
- Osteoarthritis, Arthritis, Surgery, Infection
- Trial name
- NCT01736644
- Testing
- Electrocautery, Bipolar sealer Aquamantys
- Where
- 2 sites in United Kingdom
- Volunteers
- 97 people
- Sponsor
- Medtronic Surgical Technologies