Clinical trials: Lower Extremity Injuries
- Condition Lower Extremity Injuries
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Ankle Sprain
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).
- Trial name
- NCT01037816
- Testing
- FS-67 Patch
- Where
- 23 sites in United States
- Volunteers
- 252 people
- Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
Knee Injuries
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery.
- Trial name
- NCT00226759
- Testing
- OMS103HP, Vehicle
- Where
- 20 sites in United States, Canada
- Volunteers
- 321 people
- Sponsor
- Omeros Corporation
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.
Acute Pain, Ankle Sprain
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.
- Trial name
- SUPPORT 2 (NCT00869180)
- Testing
- Diclofenac Sodium
- Where
- United States
- Volunteers
- 219 people
- Sponsor
- Cerimon Pharmaceuticals
Pelvic Ring Fracture, Acetabular Fracture
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
- Conditions
- Pelvic Ring Fracture, Acetabular Fracture, Pelvic Fracture, Pelvic Fracture Acetabulum
- Trial name
- NCT05606042
- Testing
- IM Implant
- Where
- 6 sites in United States
- Volunteers
- 53 people
- Sponsor
- CurvaFix, 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
ACL Tears
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
- Trial name
- NCT06948591
- Testing
- Anterior cruciate ligament reconstruction with BioBrace® augmentation, Arthroscopic anterior cruciate ligament reconstruction
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- CONMED Corporation
Ankle Injuries
5% Topical Ibuprofen (IBU) for Ankle Sprain
This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain.
- Trial name
- NCT01945034
- Testing
- Topical IBU twice daily, Topical IBU three times daily
- Where
- 19 sites in United States
- Volunteers
- 304 people
- Sponsor
- Pfizer
Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to…
- Trial name
- NCT03348995
- Testing
- Bridge-Enhanced ACL Restoration (BEAR)
- Where
- 11 sites in United States
- Volunteers
- 250 people
- Sponsor
- Miach Orthopaedics
Hip Fracture
Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
The objectives of this study are to assess the efficacy, safety, and tolerability of PLX-PAD intramuscular administration for the treatment of muscle injury following arthroplasty for HF.
- Trial name
- NCT03451916
- Testing
- PLX-PAD
- Where
- 17 sites in United States, Bulgaria and 3 more
- Volunteers
- 240 people
- Sponsor
- Pluristem Ltd.
Tibial Fractures
ACTiF- Assessment of Closed Tibial Fractures
The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing…
- Trial name
- NCT00533377
- Testing
- CP-533, 536, Standard of Care, CP-533,536
- Where
- 56 sites in United States, Australia and 9 more
- Volunteers
- 276 people
- Sponsor
- Pfizer
Osteoporosis
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study.
- Trial name
- NCT05202678
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- AgNovos Healthcare, LLC
Hip Fractures, Gait Disorders in Old Age
Clinical Study of the Effects of a SWalker II and VR for Hip Fracture Rehabilitation in the Elderly
This project is structured in two distinct phases. The first phase deals with the recovery of the hip fracture in the acute phase up to ambulation, and the second is understood as the continuation of functional improvement of…
- Trial name
- SWalker-VR (NCT06025981)
- Testing
- Preliminary Phase, Phase I - Early gait rehabilitation, Phase II - Maintenance gait function ( with VR)
- Where
- 2 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Werium Assistive Solutions
Dislocated Patella, Torn Medial Patellofemoral Ligament
Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation
Background: The forces involved in a patella dislocation event can cause significant collateral damage involving the articular cartilage of the patella femoral joint.
- Trial name
- NCT02185001
- Testing
- Direct Medial Patellofemoral Ligament (MPFL) Repair, Physical therapy
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Orthopedic Specialty Institute
Ankle Sprains
MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle…
- Trial name
- NCT01198834
- Testing
- MRX-7EAT, Lidocaine, Etodolac
- Where
- 33 sites in United States
- Volunteers
- 600 people
- Sponsor
- MEDRx USA, Inc.
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
Ankle Injuries, Syndesmotic Injuries
Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain
- Trial name
- NCT04893824
- Testing
- Grappler® Interference Screw System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paragon 28
Osteoporosis
GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study.
- Trial name
- NCT05966974
- Where
- Belgium
- Volunteers
- 44 people
- Sponsor
- AgNovos Healthcare, LLC
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
Fracture Arm, Fracture Leg
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.
- Conditions
- Fracture Arm, Fracture Leg, Wrist Injury, Ankle Injury
- Trial name
- NCT07853768
- Testing
- Accuro XV Ultrasound Imaging System
- Where
- 10 sites in United States
- Volunteers
- 25,000 people
- Sponsor
- Rivanna Medical, Inc.