Clinical trials: Knee Surgery
Osteoarthritis of the Knee
MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty
Overall study design: A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system.
- Trial name
- MIS GEN II (NCT00853398)
- Testing
- surgical technique
- Where
- Germany
- Sponsor
- Smith & Nephew Orthopaedics AG
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.
Articular Cartilage Disorder, Degeneration; Articular Cartilage
Neocartilage Implant to Treat Cartilage Lesions of the Knee
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to…
- Conditions
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury
- Trial name
- NCT01400607
- Testing
- Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft), Microfracture
- Where
- 9 sites in United States
- Volunteers
- 14 people
- Sponsor
- ISTO Technologies, 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 proof of concept study are to evaluate the safety and preventive analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee…
- Trial name
- NCT01731730
- Testing
- AYX1 Injection 110 mg, AYX1 Injection 330 mg
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Adynxx, Inc.
Degenerative Joint Disease, Osteoarthritis
PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain, activity level, narcotic consumption, adverse…
- Trial name
- PRECISE (NCT01081886)
- Testing
- PEAK PlasmaBlade 4.0, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Medtronic Surgical Technologies
Arthroplasty, Replacement, Knee
ZIPS Study - Zip Incision Approximation vs. STAPLE
Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
- Trial name
- ZIPS (NCT02255877)
- Testing
- Zip Surgical Skin Closure, Steel Staples
- Where
- United States
- Sponsor
- ZipLine Medical Inc.
Pain, Post Operative Pain
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.
- Trial name
- Pain (NCT00791804)
- Testing
- AeroLEF
- Where
- 2 sites in Canada
- Volunteers
- 19 people
- Sponsor
- YM BioSciences
Arthroplasty, Replacement, Prevention of Venous Thromboembolism
Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate
To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip…
- Conditions
- Arthroplasty, Replacement, Prevention of Venous Thromboembolism, Moderate Renal Impairment (CrCl 30-50 mL/Min)
- Trial name
- NCT01184989
- Testing
- Dabigatran etexilate
- Where
- 10 sites in Austria, Canada and 4 more
- Volunteers
- 142 people
- Sponsor
- Boehringer Ingelheim
Chronic Knee Pain, Chronic Knee Osteoarthritis
Treating Chronic Pain of Peripheral Nerve Origin With the Novel Noninvasive Hypersound Neuromodulation System
First, the subject will undergo screening and provide informed consent. Baseline measurements are then taken. The subject remains seated with back support throughout the session.
- Conditions
- Chronic Knee Pain, Chronic Knee Osteoarthritis, Post Surgical Neuropathic Pain
- Trial name
- NCT06626854
- Testing
- RF-PNS
- Volunteers
- 5 people
- Sponsor
- Hypersound Medical Inc
Tibial Fractures
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical…
- Trial name
- TrigenMETA (NCT01358292)
- Testing
- Semi-extended Surgical Technique, Standard Surgical Technique
- Where
- 5 sites in Germany, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Degenerative Arthritis of Knee
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched…
- Trial name
- NCT01084772
- Testing
- VISIONAIRE Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Where
- 7 sites in United States, Australia
- Volunteers
- 134 people
- Sponsor
- Smith & Nephew, Inc.
Venous Thrombosis
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery
- Trial name
- NCT00306254
- Testing
- PD 0348292, Enoxaparin
- Where
- 134 sites in United States, Australia and 14 more
- Volunteers
- 1,225 people
- Sponsor
- Pfizer
Knee Arthropathy
Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
The purpose of the study is the evaluation of the clinical and radiological long-term performance of the balanSys UNI fix in a multicenter routine clinical setting.
- Trial name
- NCT04598568
- Testing
- balanSys UNI
- Volunteers
- 116 people
- Sponsor
- Mathys Ltd Bettlach
Musculoskeletal Diseases
Medacta NextAR TKA Pivotal Trial
The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).
- Trial name
- NCT04844879
- Testing
- NextAR TKA system
- Where
- 4 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- Medacta International SA
Total Knee Replacement, Total Hip Replacement
New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery
LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from forming in the legs and may prevent those blood clots from traveling to the lungs.
- Trial name
- NCT00074828
- Testing
- LY517717, enoxaparin
- Where
- 8 sites in Australia, Austria and 6 more
- Volunteers
- 511 people
- Sponsor
- Eli Lilly and Company
Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle
Multicentre GMK UNI Anatomical Cementless Study - FR
Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee.
- Conditions
- Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle, Revision Surgery
- Trial name
- NCT06715917
- Where
- 5 sites in France, Switzerland
- Volunteers
- 249 people
- Sponsor
- Medacta International SA
Arthroplasty, Replacement, Knee, Venous Thrombosis
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism…
- Trial name
- NCT00246025
- Testing
- Dabigatran etexilate
- Where
- 38 sites in Japan
- Volunteers
- 512 people
- Sponsor
- Boehringer Ingelheim
Osteoarthritis of the Knee, Total Knee Replacement
Prophecy Guide Outcomes in Total Knee Replacement Surgery
This project aims to assess two different techniques used to position the knee replacement implant during surgery. The patients will be randomised to receive either the following: 1.
- Trial name
- NCT01163708
- Testing
- Prophecy Technique, Navigation System
- Where
- 2 sites in Australia
- Volunteers
- 188 people
- Sponsor
- Global Orthopaedic Technology
Articular Cartilage Disorder of Knee, Articular Cartilage; Degeneration
Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint…
- Trial name
- NCT03101163
- Testing
- Autologous peripheral blood stem cells and hyaluronic acid, Hyaluronic acid
- Where
- 2 sites in United States, Malaysia
- Volunteers
- 120 people
- Sponsor
- KLSMC Stem Cells, Inc.
Defect of Articular Cartilage, Osteochondritis Dissecans
Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.
- Trial name
- CAIS (NCT00881023)
- Testing
- Microfracture, Cartilage Autograft Implantation System
- Where
- 29 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- DePuy Mitek