Clinical trials: Lower Limb Injury
Knee Injuries
Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.
- Trial name
- NCT02270905
- Testing
- dCELL® Meniscus
- Where
- 4 sites in Poland, United Kingdom
- Volunteers
- 32 people
- Sponsor
- Tissue Regenix Ltd
ACL Reconstruction
Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a…
- Trial name
- NCT03355651
- Testing
- PROGEN
- Volunteers
- 80 people
- Sponsor
- OPKO Health, Inc.
Spinal Cord Injuries, Paraplegia
ExoAtlet II For SCI Patients
This study will evaluate the ExoAtlet II exoskeleton for safety and effectiveness of providing persons with a spinal cord injury (SCI) who are non-ambulatory or have limited ambulatory function, to stand up and ambulate under a…
- Trial name
- EXOATLET2SCI (NCT04215081)
- Testing
- Gait training using ExoAtlet exoskeleton
- Where
- Russia
- Volunteers
- 20 people
- Sponsor
- COSMO ROBOTICS CO., Ltd
Anterior Cruciate Ligament Injury, Osteoarthritis
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction
The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction
- Trial name
- NCT01088191
- Testing
- MSB-CAR001 Combined With Hyaluronan, Hyaluronan
- Where
- Australia
- Volunteers
- 17 people
- Sponsor
- Mesoblast, Ltd.
Diabetic Foot Ulcer (DFU), Lower Extremity
Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care.
- Trial name
- NCT07116876
- Testing
- Graft Application, Wound Dressing Material
- Where
- 17 sites in United States
- Volunteers
- 120 people
- Sponsor
- LifeNet Health
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or…
- Trial name
- PATTERN (NCT03992404)
- Testing
- NT 201
- Where
- 71 sites in United States, Belgium and 13 more
- Volunteers
- 603 people
- Sponsor
- Merz Pharmaceuticals GmbH
Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA)
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.
- Conditions
- Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head
- Trial name
- OR3O (NCT04941729)
- Testing
- OR3O™ - Dual Mobility System, Conventional
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
Fractures, Bone, Nonunion of Fracture
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union…
- Conditions
- Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited
- Trial name
- NCT04299022
- Testing
- Vivigen Cellular Bone Matrix
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- LifeNet Health
Tibial Fractures
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled.
- Trial name
- NCT04015167
- Testing
- T2 Alpha Tibia Nailing System
- Where
- 4 sites in United States
- Volunteers
- 103 people
- Sponsor
- Stryker Trauma and Extremities
Tibial Fracture
Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture
Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the…
- Trial name
- ALLOB-TF2 (NCT04432389)
- Testing
- ALLOB
- Where
- 39 sites in Belgium, Czechia and 5 more
- Volunteers
- 178 people
- Sponsor
- Bone Therapeutics S.A
Diabetic Foot Ulcer
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally…
- Trial name
- NCT00764361
- Testing
- doxycycline
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- NanoSHIFT LLC
Healthy, Osteopenia
Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-BMD (NCT07187518)
- Testing
- Measurements with the POROUS R4C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine
- Where
- 2 sites in Germany
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
Degenerative Osteoarthritis, Rheumatic Arthritis
CoreHip - Post Market Clinical Follow-Up Study
The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU).
- Conditions
- Degenerative Osteoarthritis, Rheumatic Arthritis, Fractures, Hip, Necrosis, Femur Head
- Trial name
- NCT03685110
- Testing
- CoreHip Total Hip Arthroplasty
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 248 people
- Sponsor
- Aesculap AG
Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed…
- Conditions
- Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds, Lower Extremity Mixed Aetiology Leg Wounds
- Trial name
- NCT01417208
- Testing
- SNaP® Wound Care System
- Where
- United Kingdom
- Sponsor
- KCI USA, Inc
Knee Injuries, Anterior Cruciate Ligament (ACL) Reconstruction
OrthoPure™ XT Pilot Clinical Study
To evaluate the clinical safety and obtain preliminary effectiveness data for OrthoPure™ XT device in a small group of US patients at 12 and 24 months.
- Trial name
- NCT03562299
- Testing
- OrthoPure™ XT
- Where
- 3 sites in United States
- Sponsor
- TRX Orthopedics
Leg Ulcers, Diabetic Foot Ulcer
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
The goal of this clinical trial is to learn if vacuum compression therapy added to standard care improves wound healing in adults with chronic lower limb ulcers.
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Trial name
- NCT07737184
- Testing
- Vacuum Compression Therapy (VCT), Standardized Wound Care
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- BTL Industries Ltd.
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
Wound Heal
VistaCare® in the Treatment of Wounds of the Lower Extremity
Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.
- Trial name
- NCT03790202
- Testing
- VistaCare®
- Where
- 5 sites in France
- Volunteers
- 30 people
- Sponsor
- DTAMedical SAS
Total Hip Arthroplasty, Degenerative Joint Disease of Hip
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and…
- Conditions
- Total Hip Arthroplasty, Degenerative Joint Disease of Hip, Avascular Necrosis of Hip, Rheumatoid Arthritis of Hip
- Trial name
- NCT04754087
- Testing
- Vivacit-E and Longevity (HXLPE) Liners
- Where
- 11 sites in United States, Denmark and 3 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet