Clinical trials: Lower Limb
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
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
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
Sickle Cell Disease, Leg Ulcers
Resolution of Sickle Cell Leg Ulcers With Voxelotor
This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease.
- Trial name
- RESOLVE (NCT05561140)
- Testing
- Voxelotor Oral Tablet
- Where
- 23 sites in Brazil, Kenya and 1 more
- Volunteers
- 88 people
- Sponsor
- Pfizer
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.
Knee Injuries
Efficacy and Safety of OMS103HP in Patients Undergoing Autograft 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
- NCT00226772
- Testing
- OMS103HP, Vehicle
- Where
- 18 sites in United States, Canada
- Volunteers
- 326 people
- Sponsor
- Omeros Corporation
Varicose Ulcer
Cost Evaluation of Venous Leg Ulcers Management
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.
- Trial name
- EPIC (NCT02728986)
- Testing
- Profore, Coban2
- Where
- France
- Volunteers
- 176 people
- Sponsor
- Solventum US LLC
Diabetes Mellitus, Foot Ulcer
Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes
The purpose of this study is to evaluate risk of cancer incidence and mortality associated with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S. Veterans Health Administration.
- Conditions
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot, Diabetic Neuropathies
- Trial name
- NCT01235260
- Testing
- Becaplermin nonusers, Becaplermin users
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
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
Diabetic Foot Ulcer
Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised treatment, over a 16 week period conducted at out-patient level, utilising novel optical wound measurement technologies.
- Trial name
- NCT02967900
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Michelson Diagnostics 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
Anterior Cruciate Ligament Injuries
A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
- Trial name
- NCT05398341
- Testing
- The BEAR® Implant
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- Miach Orthopaedics
Femur Fracture
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.
- Trial name
- PLN (NCT00725894)
- Testing
- Pediatric Locking Nail
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Zimmer Biomet
Lower Limb Spasticity Due to Cerebral Palsy
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle…
- Trial name
- NCT01893411
- Testing
- IncobotulinumtoxinA (16 Units per kg body weight), IncobotulinumtoxinA (12 Units per kg body weight), IncobotulinumtoxinA (4 Units per kg body weight)
- Where
- 53 sites in Austria, Czechia and 12 more
- Volunteers
- 311 people
- Sponsor
- Merz Pharmaceuticals GmbH
Femoral Fractures, Tibial Fractures
Depuy Synthes Lower Extremity Shaft Nail Registry
The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA)…
- Trial name
- NCT05272631
- Testing
- Retrograde Femoral Nail Advanced, Tibial Nail Advanced
- Where
- 8 sites in United States
- Volunteers
- 241 people
- Sponsor
- DePuy Synthes Products, Inc.
Sprain of Ankle
Evaluation of the Effect of the Association of Proton Pump Inhibitor (PPIs) With Non-Steriodal Anti-Inflamatories (NSAIDs) in Work Leave Time.
Retrospective cohort study to evaluate the effect of the association of PPIs with NSAIDs in work leave time.
- Trial name
- NCT00717119
- Where
- Spain
- Volunteers
- 6,356 people
- Sponsor
- AstraZeneca
Cerebral Palsy, Muscle Spasticity
Dysport® Pediatric Lower Limb Spasticity Study
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy.
- Conditions
- Cerebral Palsy, Muscle Spasticity, Children
- Trial name
- NCT01249417
- Testing
- Botulinum toxin type A
- Where
- 29 sites in United States, Chile and 4 more
- Volunteers
- 241 people
- Sponsor
- Ipsen
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
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.