Clinical trials: Orthopedic Operations
Venous Thromboembolism
Dose-confirmatory Bridging Study in Total Knee Replacement
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing…
- Trial name
- NCT01206972
- Testing
- Rivaroxaban (BAY59-7939), Enoxaparin
- Where
- 33 sites in Japan
- Volunteers
- 302 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
Blood Transfusion, Orthopedic Procedures
A Study to Determine the Safety of Epoetin Alfa and Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients After Major Orthopedic Surgery.
The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery.
- Conditions
- Blood Transfusion, Orthopedic Procedures, Anemia
- Trial name
- NCT00270036
- Testing
- epoetin alfa
- Volunteers
- 1 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Pain
A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.
- Trial name
- NCT05375305
- Testing
- SHR8554 Injection, Saline Solution, Morphine
- Where
- China
- Volunteers
- 320 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Anemia, Blood Transfusion
A Study to Determine Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients During the Period of Time Around Major Orthopedic Surgery.
The purpose of this study is to evaluate the safety of epoetin alfa and to determine whether epoetin alfa will reduce the need for blood transfusions during the period of time around major orthopedic surgery.
- Conditions
- Anemia, Blood Transfusion, Orthopedic Procedures
- Trial name
- NCT00270088
- Testing
- epoetin alfa
- Volunteers
- 316 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Osteoarthritis of Knee, Edema
Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery
The purpose of this study is to determine if patients undergoing a total knee arthroplasty (TKA) experience a clinically significant reduction in healing time when treated post operatively with a specific form of micro and…
- Conditions
- Osteoarthritis of Knee, Edema, Wounds and Injuries
- Trial name
- NCT02623660
- Testing
- ODIN1, Standard Care, Diagnostic Device Testing
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bioelectric Research Corporation
Prevention, Venous Thromboembolism
Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.
- Trial name
- RECORD 2 (NCT00332020)
- Testing
- Rivaroxaban (BAY59-7939), Enoxaparin
- Where
- 126 sites in United States, Australia and 21 more
- Volunteers
- 2,457 people
- Sponsor
- Bayer
Postoperative Pain Management
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine…
- Trial name
- NCT07186426
- Testing
- HSK21542, morphine
- Where
- 2 sites in China
- Volunteers
- 405 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Postoperative Analgesia After Unilateral Hallux Valgus Correction Surgery
To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery
This is a multicenter, randomized, double-blind, placebo-controlled phase Ib study designed to evaluate the safety, efficacy and PK of TRD205 tablets administered orally .
- Trial name
- TRD205 (NCT07121023)
- Testing
- TRD205 tablets
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Beijing Tide Pharmaceutical Co., Ltd
Prophylaxis, Thromboembolism, Venous, Total Knee Replacement
Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)
The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR
- Conditions
- Prophylaxis, Thromboembolism, Venous, Total Knee Replacement, Total Hip Replacement
- Trial name
- XYRIS (NCT01523418)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Sponsor
- Bayer
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.
Anemia, Blood Transfusion
A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery.
The purpose of this study is to determine an effective dose of epoetin alfa to be administered prior to surgery, to decrease the need for blood transfusions during hip replacement.
- Conditions
- Anemia, Blood Transfusion, Orthopedic Surgery
- Trial name
- NCT00269971
- Testing
- epoetin alfa
- Sponsor
- Janssen-Ortho Inc., Canada
Orthopedic Disorders, Surgical Site Infection
Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial
Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes.
- Trial name
- DECO-SSI (NCT02560155)
- Testing
- Mupirocin 2% nasal ointement, Chlorhexidine sol 4%
- Where
- Switzerland
- Volunteers
- 1,300 people
- Sponsor
- Lindenhofgruppe AG
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270023
- Testing
- epoetin alfa
- Volunteers
- 112 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Pain
Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
- Trial name
- NCT00286065
- Testing
- AeroLEF
- Where
- Canada
- Volunteers
- 123 people
- Sponsor
- YM BioSciences
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)
This is a local, prospective, multicenter, non-interventional, observational study. Primary objective is to describe how in "real life" thromboprophylaxis is carried out after the discharge from a hospital in the patients who…
- Trial name
- SOPRANO (NCT01444586)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Russia
- Volunteers
- 2,293 people
- Sponsor
- Bayer
Hypovolemia, Hemorrhage
Trial of 6% HES130/0.4
The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of…
- Trial name
- NCT01010022
- Testing
- 6% hydroxyethyl starch 130/0.4, 6% hydroxyethyl starch 70/0.5 (Salinhes®)
- Where
- 7 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Fresenius Kabi Japan
Degenerative and Traumatic Pathology of the Knee, Degenerative and Traumatic Pathology of the Shoulder and Elbow
Web Based Orthopaedic Sports Medicine Registry
The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent…
- Conditions
- Degenerative and Traumatic Pathology of the Knee, Degenerative and Traumatic Pathology of the Shoulder and Elbow, Degenerative and Traumatic Pathology of the Foot and Ankle, Degenerative and Traumatic Pathology of the Hand and Wrist
- Trial name
- NCT01191151
- Where
- 258 sites in United States, Canada and 3 more
- Volunteers
- 12,500 people
- Sponsor
- Arthrex, Inc.