Clinical trials: Orthopedic Surgery of Lower Limb
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.
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
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Osteoporosis, Hip Fracture
Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture
The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new)…
- Trial name
- NCT00046254
- Testing
- Zoledronic Acid
- Where
- 28 sites in United States, Germany
- Volunteers
- 2,127 people
- Sponsor
- Novartis Pharmaceuticals
Fracture of Lower Limb
Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.
The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
- Trial name
- NCT01308047
- Testing
- Bupivacaine
- Where
- 2 sites in Brazil
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Tibial Fracture
Assessment of the Verus Frame in Tibial Intramedullary Nailing
This prospective, single-arm Post-Market Clinical Follow-Up (PMCF) study, utilizing a registry-based control group, will assess the Verus frame's effectiveness in achieving precise tibial rotation and alignment during…
- Trial name
- NCT07362121
- Testing
- Verus frame to stabilize tibia
- Where
- Finland
- Volunteers
- 25 people
- Sponsor
- Hemitec Finland Oy
Orthopedic Disorder of Spine
Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.
Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in spinal anesthesia.
- Trial name
- NCT01994967
- Testing
- Levobupivacaine, Bupivacaine
- Where
- 5 sites in Brazil
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.