Clinical trials: Lower Limb Injury
Wounds
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
The purpose of this study is to determine: 1. If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy. 2.
- Trial name
- NCT00234559
- Testing
- VAC® Therapy System
- Sponsor
- KCI USA, Inc
Post-stroke Spasticity, Spasticity Post-Traumatic Brain Injury
Dysport® Adult Lower Limb Spasticity Follow-on Study
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
- Trial name
- NCT01251367
- Testing
- Botulinum toxin type A
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 352 people
- Sponsor
- Ipsen
Bone Fracture, Tibia Fracture
Efficacy and Safety of SurgiFill™in Patients With Femur or Tibia Fracture
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
- Conditions
- Bone Fracture, Tibia Fracture, Femur Fracture
- Trial name
- NCT07518836
- Testing
- femur or tibia fracture, SurgiFill™
- Where
- 3 sites in South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Lower Extremity Chronic Ulcers in Diabetics
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
- Trial name
- NCT01421966
- Testing
- CureXcell®
- Where
- 37 sites in United States, Canada and 1 more
- Volunteers
- 285 people
- Sponsor
- Macrocure Ltd.
Knee Osteoarthritis (Knee OA)
Knee OsteoArthritis Long-term Assessment
The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is…
- Trial name
- KOALA (NCT06839222)
- Testing
- Hydrogel OA 2%, Hyaluronic Acid (Durolane)
- Where
- 5 sites in Belgium
- Sponsor
- Allegro NV/SA
Fracture Femur, Fracture Tibia
Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs.
- Trial name
- CETIULTRA-BONE (NCT07299851)
- Testing
- CFA-based food supplement
- Where
- 6 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Pharmanutra S.p.a.
Knee Injuries
Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols…
- Trial name
- NCT01246895
- Testing
- Microfracture with BST-CarGel, Microfracture without BST-CarGel
- Where
- 16 sites in Canada, Spain
- Volunteers
- 67 people
- Sponsor
- Piramal Healthcare Canada Ltd
Anterior Cruciate Ligament Tear
Bridge-Enhanced ACL Repair vs ACL Reconstruction
The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
- Trial name
- NCT02664545
- Testing
- BEAR Scaffold, Tendon Graft
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Miach Orthopaedics
Femoral Fractures, Hip Fractures
A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models)
This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation.
- Trial name
- NCT04865146
- Testing
- TRIGEN™ INTERTAN™
- Where
- 7 sites in China
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
Spasticity
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension…
- Trial name
- NCT04099667
- Testing
- Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 3; MYOBLOC
- Where
- 9 sites in United States, Hungary and 1 more
- Volunteers
- 40 people
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Hip Osteoarthritis
OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study
The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation
- Trial name
- NCT02353377
- Testing
- OXINIUM DH Hip System, BIOLOX◊
- Volunteers
- 413 people
- Sponsor
- Smith & Nephew, Inc.
Tibial Fractures
Multiregion BHA in Open Tibia Fractures
This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open…
- Trial name
- NCT04056429
- Testing
- BHA
- Sponsor
- Carmell Therapeutics Corporation
Bone Fracture, Radius Fracture
Study on Wood-plastic Composite for Circumferential Casting
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.
- Conditions
- Bone Fracture, Radius Fracture, Ankle Fracture
- Trial name
- WOODCAST (NCT01493167)
- Testing
- limb casting/splinting
- Where
- Finland
- Volunteers
- 97 people
- Sponsor
- Onbone Oy
Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic
Cemented TrendHip® - Multicenter PMCF Study on Total Indications
This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational…
- Conditions
- Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis
- Trial name
- TRESTI (NCT04943328)
- Testing
- Total Hip Arthroplasty
- Where
- 4 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Aesculap AG
Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
Compartment Syndrome
Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time.
- Trial name
- NCT01077934
- Testing
- near-infrared spectroscopy
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- J&M Shuler
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Non-inflammatory Degenerative Joint Disease, Osteoarthritis
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Requires Correction of Functional Deformity
- Trial name
- CORI RCT UKA (NCT04797897)
- Testing
- CORI, Conventional
- Where
- 3 sites in Australia, Hong Kong and 1 more
- Volunteers
- 4 people
- Sponsor
- Smith & Nephew, Inc.
Tibial Fractures, Fracture Infection
Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.
- Trial name
- NCT05022485
- Testing
- ZNN Bactiguard tibia
- Where
- 16 sites in Austria, France and 6 more
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet
Femoral Fractures
Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2
This is an observational, retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before…
- Trial name
- NCT01599221
- Testing
- EBA2
- Where
- 3 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Citieffe S.r.l