Clinical trials: Orthopedic Surgery
Hemostasis
HEMOBLAST Pivotal Clinical Investigation
The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.
- Trial name
- NCT02780869
- Testing
- HEMOBLAST Bellows, Absorbable gelatin sponge, USP with thrombin
- Where
- 17 sites in United States
- Volunteers
- 258 people
- Sponsor
- Biom'Up France SAS
Venous Thromboembolism
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal…
- Trial name
- NCT01857583
- Testing
- 15mg DU-176b, 30mg DU-176b, Fondaparinux
- Where
- Japan
- Volunteers
- 80 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Central Nervous System Infections, Pseudotumor Cerebri
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
- Conditions
- Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer
- Trial name
- NCT04796935
- Testing
- Tactile Imaging (VerTouch), Control (palpation)
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- IntuiTap Medical, Inc
Postoperative Pain, Total Knee Replacement
Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System
The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg.
- Conditions
- Postoperative Pain, Total Knee Replacement, Total Knee Arthroplasty, Partial Knee Replacement
- Trial name
- NCT04341948
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 10 sites in United States
- Volunteers
- 56 people
- Sponsor
- SPR Therapeutics, Inc.
Arthroscopic Knee Surgery
A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery
The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a…
- Trial name
- NCT01650519
- Testing
- IV ibuprofen, IV ketorolac
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Cumberland Pharmaceuticals
Hemostasis
HEMOBLAST Pilot Clinical Investigation
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting.
- Trial name
- NCT02502019
- Testing
- HEMOBLAST Bellows
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Biom'Up France SAS
Surgery
Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.
- Trial name
- Annexa-S (NCT04233073)
- Testing
- andexanet alfa
- Where
- 56 sites in United States, Austria and 4 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Opioid-induced Constipation
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.
- Trial name
- NCT00640146
- Testing
- Methylnaltrexone bromide
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Bausch Health Americas, Inc.
Acute Postoperative Pain, Bunionectomy
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
- Trial name
- NCT04855240
- Testing
- ACP-044 Dose A, ACP-044 Dose B
- Where
- 4 sites in United States
- Volunteers
- 239 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Postoperative Pain
Maxigesic® IV Phase 3 Exposure Study
The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.
- Trial name
- NCT04005755
- Testing
- Maxigesic® IV
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 232 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
Venous Thromboembolism
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.
- Trial name
- RECORD 4 (NCT00362232)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin
- Where
- 124 sites in United States, Bulgaria and 11 more
- Volunteers
- 3,148 people
- Sponsor
- Bayer
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.
Pain, Postoperative
An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery
The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine…
- Trial name
- NCT00766506
- Testing
- Fentanyl IONSYS, Morphine IV PCA
- Where
- 7 sites in United Kingdom
- Volunteers
- 108 people
- Sponsor
- Janssen-Cilag Ltd.
Venous Thromboembolism
Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant…
- Trial name
- NCT01139658
- Where
- 53 sites in France
- Volunteers
- 1,676 people
- Sponsor
- Boehringer Ingelheim
Hemophilia A
Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery
The purpose of this study is to compare the hemostatic efficacy and safety of continuous infusion versus intermittent bolus infusion in the peri- and post-operative setting, employing rAHF-PFM, a recombinant antihemophilic factor…
- Trial name
- NCT00357656
- Testing
- Recombinant Protein-Free Factor VIII (rAHF-PFM)
- Where
- 36 sites in United States, Austria and 12 more
- Volunteers
- 85 people
- Sponsor
- Baxalta now part of Shire
Postoperative Pain
Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.
- Trial name
- NCT00507026
- Testing
- IV Diclofenac, IV ketorolac
- Where
- 8 sites in United States
- Volunteers
- 277 people
- Sponsor
- Pfizer
Pain
Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen)…
- Trial name
- NCT00470600
- Testing
- Caldolor, Normal Saline
- Where
- 9 sites in United States, South Africa
- Volunteers
- 185 people
- Sponsor
- Cumberland Pharmaceuticals
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
Pain, Nausea
A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV
To determine the analgesic efficacy of CL-108 5 mg by comparison with placebo and the anti-emetic efficacy of CL-108 5 mg by comparison with hydrocodone 5 mg/acetaminophen 325 mg.
- Conditions
- Pain, Nausea, Vomiting
- Trial name
- NCT03657810
- Testing
- CL-108 5 mg, Norco
- Where
- 5 sites in United States
- Volunteers
- 349 people
- Sponsor
- Charleston Laboratories, Inc
Arthroplasty, Knee Replacement, Wound Healing
Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.
- Trial name
- NCT02460172
- Testing
- Zip Surgical Skin Closure, Steel Staples
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- ZipLine Medical Inc.