Clinical trials: Lower Limb Surgery
Lower Extremity Surgery, Bunion
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
- Conditions
- Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion
- Trial name
- STRIDE (NCT04518462)
- Testing
- Exparel, Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 121 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Pain, Chronic, Pain, Intractable
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety, comfort and compliance with the Nalu Neurostimulation System in adult…
- Conditions
- Pain, Chronic, Pain, Intractable, Pain, Back
- Trial name
- nPower™-US (NCT04503109)
- Testing
- Nalu Neurostimulation System
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Nalu Medical, Inc.
Fracture;Pelvis, Sacral Fracture
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
- Conditions
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture
- Trial name
- SAFFRON (NCT05426356)
- Testing
- Surgical Intervention, Non-Surgical Management
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- SI-BONE, Inc.
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Spinal Anesthesia, Vascular Surgery
Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery
This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.
- Trial name
- NCT03883763
- Testing
- bupivacaine S75:R25 plus 8% glucose, bupivacaine S50:R50 plus 8% glucose
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Venous Thromboembolism
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.
- Trial name
- NCT00937911
- Testing
- YM150
- Where
- 8 sites in Japan
- Volunteers
- 101 people
- Sponsor
- Astellas Pharma Inc
Thrombosis, Venous
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by…
- Trial name
- FONDACAST (NCT00843492)
- Testing
- Fondaparinux sodium, Nadroparin
- Where
- 122 sites in France, Germany and 4 more
- Volunteers
- 1,351 people
- Sponsor
- GlaxoSmithKline
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Coronary Heart Failure
Evaluate Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery
The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation.
- Trial name
- NCT00514241
- Testing
- The GPS™ II Platelet Concentrate Separation Kit
- Where
- Norway
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
Failed Back Surgery Syndrome, Post-Laminectomy Syndrome
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.
- Conditions
- Failed Back Surgery Syndrome, Post-Laminectomy Syndrome, Low Back Pain
- Trial name
- SENSE (NCT01990287)
- Testing
- SCS and PNfS, SCS Alone
- Where
- 28 sites in United States
- Volunteers
- 38 people
- Sponsor
- Abbott Medical Devices
Bunion, Metatarsophalangeal Fusion
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
- Conditions
- Bunion, Metatarsophalangeal Fusion, Midfoot Fusion, Hindfoot Fusion
- Trial name
- STRIDE (NCT03954639)
- Testing
- EXPAREL 13.3Mg/mL Suspension for Injection, Bupivacaine Hydrochloride
- Sponsor
- Pacira Pharmaceuticals, Inc
Peripheral Arterial Disease, Peripheral Artery Disease
FRAME, External Support for Lower Limb Autologous Grafts
30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment…
- Trial name
- NCT04003480
- Testing
- FRAME
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vascular Graft Solutions Ltd.
Anesthesia,Spinal
Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery
The purpose of this study is to compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml when used for…
- Trial name
- NCT00358280
- Testing
- Ropivacaine, Bupivacaine
- Where
- 5 sites in China
- Volunteers
- 220 people
- Sponsor
- AstraZeneca
Wounds and Injuries, Burns
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed
- Trial name
- SIDDX (NCT06328010)
- Testing
- Various types of wound care treatments
- Where
- 12 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Siddhey LLC
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions Ltd.
Knee Injuries, Joint Surface Knee Lesions
A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee
The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data.
- Trial name
- NCT06916728
- Testing
- Marketed Product - MP01, Surgical Standard of Care
- Where
- 8 sites in United States, Belgium and 4 more
- Volunteers
- 170 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot, Varicose Ulcer
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
The purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers.
- Conditions
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
- Trial name
- NCT00521027
- Testing
- Versajet Hydrosurgery System, Conventional surgical debridement techniques
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Smith & Nephew, Inc.
Hip Arthritis, Osteoarthritis, Hip
Observational Study to Collect Safety Data and PROMs on Primary THA
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
- Conditions
- Hip Arthritis, Osteoarthritis, Hip, Coxitis, Femoral Head Necrosis
- Trial name
- NCT06518993
- Testing
- Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Corin
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
Hip Fractures, Hip Hemiarthroplasty
Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty
This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.
- Conditions
- Hip Fractures, Hip Hemiarthroplasty, Osteoarthritis, Hip, Avascular Necrosis of Hip
- Trial name
- NCT05686278
- Testing
- Bipolar i and cemented stem (Océane+ or Meije)
- Where
- 4 sites in France
- Volunteers
- 368 people
- Sponsor
- Corin