Clinical trials: Orthopaedic Surgery
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
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.
Pain, Postoperative
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe…
- Trial name
- NCT00779038
- Testing
- Fentanyl ITS
- Where
- 3 sites in Belgium
- Volunteers
- 13 people
- Sponsor
- Janssen Cilag N.V./S.A.
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
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.
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
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
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
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.
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
Deep Vein Thrombosis
A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.
- Trial name
- NCT02368314
- Testing
- Sodium Enoxaparine
- Where
- Russia
- Volunteers
- 124 people
- Sponsor
- Biocad
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.
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.
Arthritis, Osteoarthritis, Knee
Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement
The study will describe the short-term effects the study drug, rivaroxaban, has on the body when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by mouth) for the prevention of blood clotting in…
- Conditions
- Arthritis, Osteoarthritis, Knee, Osteoarthritis, Hip, Thromboembolism
- Trial name
- NCT01094886
- Testing
- Rivaroxaban
- Where
- 5 sites in United States
- Volunteers
- 56 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
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
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
Venous Thromboembolism
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
The objective of this study is to observe the safety, tolerability, and compliance in the use of Fragmin® for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.
- Trial name
- NCT01046903
- Testing
- Fragmin® (Dalteparin Sodium)
- Volunteers
- 503 people
- Sponsor
- Pfizer
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
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.
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.