Clinical trials: Lower Extremity Surgery
Failed Back Surgery Syndrome
Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain
Spinal cord stimulation (SCS) has been used for over 40 years to treat neuropathic pain. Various clinical studies have shown a beneficial effect of SCS on pain in patients with Failed Back Surgery Syndrome (FBSS).
- Trial name
- NCT01096147
- Testing
- Spinal cord stimulation with eight polar electrode
- Where
- 8 sites in Belgium, Norway and 1 more
- Volunteers
- 80 people
- Sponsor
- Rik Buschman, PhD
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.
Failed Back Surgery Syndrome, Back Pain
Spinal Cord Stimulation for Predominant Low Back Pain
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering…
- Conditions
- Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
- Trial name
- PROMISE (NCT01697358)
- Testing
- Spinal Cord Stimulation (SCS), Optimal Medical Management (OMM)
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 278 people
- Sponsor
- MedtronicNeuro
Arterial Occlusive Diseases
Study of Alfimeprase's Ability to Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery
The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.
- Trial name
- NCT00338585
- Testing
- alfimeprase
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- ARCA Biopharma, Inc.
Femoral Fractures
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery.
- Trial name
- NCT00824564
- Testing
- Tranexamic Acid plus standard of care, Standard of care
- Where
- India
- Volunteers
- 82 people
- Sponsor
- Pfizer
Arterial Occlusive Diseases
Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries
The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.
- Trial name
- NCT00115999
- Testing
- alfimeprase
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- ARCA Biopharma, Inc.
Chronic Pain
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal…
- Trial name
- SOLIS (NCT04676022)
- Testing
- WaveWriter, Conventional Medical Managament
- Where
- 23 sites in United States
- Volunteers
- 241 people
- Sponsor
- Boston Scientific Corporation
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.
Hip Osteoarthritis, Avascular Necrosis
Insignia™ Hip Stem Outcomes Study
The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
- Conditions
- Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis
- Trial name
- NCT05144191
- Testing
- Insignia uncemented Hip Stem
- Where
- 11 sites in United States
- Volunteers
- 313 people
- Sponsor
- Stryker Orthopaedics
Anterior Cruciate Ligament Rupture
Tolerance, Efficacy, revAlidation, Myostim
Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament.
- Trial name
- NCT04684771
- Testing
- MYOSTIM®
- Where
- 2 sites in Belgium
- Volunteers
- 35 people
- Sponsor
- Alternativa International S.A
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.
Arterial Bypass Graft Surgery
A Feasibility Study to Evaluate Skin Cleansing With a Sodium Hypochlorite Wash
Feasibility study in approximately 20 subjects to investigate the rate of infection with subjects undergoing elective lower extremity arterial bypass graft surgery or femoral endarterectomy.
- Trial name
- NCT03534388
- Testing
- Sodium Hypochlorite Cleanser
- Where
- United States
- Sponsor
- TopMD Skin Care, Inc.
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
Delirium
Hip Fracture Surgery in Elderly Patients
The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with…
- Trial name
- HIPELD (NCT01199276)
- Testing
- Xenon, Sevoflurane
- Where
- 13 sites in Belgium, France and 4 more
- Volunteers
- 256 people
- Sponsor
- Air Liquide Santé International
Leg Injuries, Winter Sport Resorts
Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort
The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin complications in patients with a lower limb trauma supported by physicians of mountain.
- Conditions
- Leg Injuries, Winter Sport Resorts, Outpatients
- Trial name
- M2M-Thrombose (NCT01303523)
- Where
- 28 sites in France
- Volunteers
- 1,627 people
- Sponsor
- Floralis
Hip Surgery Corrective, Knee Injuries
Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings
The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit.
- Trial name
- MxBPo02 (NCT02653183)
- Testing
- Active Comparator: Aquacel Surgical, Experimental: Mepilex Border Post-Op
- Where
- 3 sites in Belgium, Sweden
- Volunteers
- 118 people
- Sponsor
- Molnlycke Health Care AB
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
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
Foot Injuries and Disorders
Nutritional Supplements and Foot Surgery
This is a prospective randomized trial wherein participants will be assigned to NutraHeal™, NutraHeal Plus™, or standard of care for 1 week prior to foot surgery and 3 weeks after surgery.
- Trial name
- NCT05522179
- Testing
- NutraHeal, NutraHeal Plus
- Where
- 3 sites in United States
- Volunteers
- 46 people
- Sponsor
- NutraHeal
Venous Thromboembolism, Embolism and Thrombosis
Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)
The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.
- Conditions
- Venous Thromboembolism, Embolism and Thrombosis, Hip Fractures
- Trial name
- NCT00119457
- Testing
- TTP889
- Where
- 21 sites in Czechia, Denmark and 2 more
- Volunteers
- 300 people
- Sponsor
- vTv Therapeutics