Clinical trials: Lower Limb Injury
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
Diabetic Ulcer
Evaluation of Topical Wound Oxygen (two2) Therapy
The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.
- Trial name
- NCT00871312
- Testing
- Topical wound oxygen therapy
- Where
- 3 sites in United States, Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- AOTI Ltd.
ACL Injury, ACL Tear
Comparison of Six-Month Functional Outcomes Following Anterior Cruciate Ligament (ACL) Reconstruction Using Peroneus Longus Tendon Grafts With Adjunctive Secretome Injection Versus Without Secretome Injection
Anterior cruciate ligament (ACL) reconstruction is commonly performed to restore knee stability after ACL injury; however, graft healing remains a critical determinant of successful outcomes.
- Trial name
- Secretome ACL (NCT07723625)
- Testing
- Secretome
- Where
- Indonesia
- Volunteers
- 24 people
- Sponsor
- PT. Prodia Stem Cell Indonesia
Fragility Fracture, Hip Fractures
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures.
- Conditions
- Fragility Fracture, Hip Fractures, Osteoporosis
- Trial name
- NCT04796350
- Testing
- AGN1 LOEP treatment
- Where
- 66 sites in Austria, Belgium and 9 more
- Volunteers
- 2,400 people
- Sponsor
- AgNovos Healthcare, LLC
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
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
Wrist Injury, Tibial Fracture
Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury
To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.
- Conditions
- Wrist Injury, Tibial Fracture, Hip Injury
- Trial name
- TOMO (NCT01927575)
- Testing
- Standard X-Ray + CT, Standard X-Ray + MRI, TOMO
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Meniscus Tears, Loose Bodies
Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee
The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries).
- Conditions
- Meniscus Tears, Loose Bodies, Articular Osteoarthritis, Articular or Capsular Trauma
- Trial name
- VSI-001 (NCT01695720)
- Testing
- VisionScope Imaging (VSI) Exam
- Where
- 7 sites in United States
- Volunteers
- 105 people
- Sponsor
- VisionScope Technologies
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
Diabetic Foot Ulcer, Type 1 Diabetes Mellitus
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2…
- Conditions
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Neuroischemic Foot Ulcer
- Trial name
- NCT06810726
- Testing
- Platelet Rich Plasma
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Estar Medical dba Medical Technologies, LTD
Osteoarthritis of First Metatarsalphalangeal Joint
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
- Trial name
- NCT00969969
- Testing
- Arthrodesis, Cartiva
- Where
- 12 sites in Canada, United Kingdom
- Volunteers
- 236 people
- Sponsor
- Cartiva, Inc.
Hip Osteoarthritis, Hip Disease
MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants…
- Conditions
- Hip Osteoarthritis, Hip Disease, Hip Fractures, Hip Injuries
- Trial name
- NCT04093739
- Testing
- G7 Freedom Constrained Liners
- Sponsor
- Zimmer Biomet
Femoral Fracture
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of 50 subjects will be enrolled at up to 5 sites. Enrollment is estimated to commence in Q4 of 2018.
- Trial name
- NCT04015154
- Testing
- Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Stryker Trauma and Extremities
Bimalleolar Ankle Fractures
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization.
- Trial name
- NCT02688855
- Testing
- Active Combined Magnetic Field OL1000 Bone Growth Stimulator
- Where
- 9 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Encore Medical, L.P.
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.
Hip Fractures, Subtrochanteric Fractures
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
This is an observational, prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl, in agreement with its Notified Body.
- Conditions
- Hip Fractures, Subtrochanteric Fractures, Intertrochanteric Fractures, Pertrochanteric Fracture
- Trial name
- Chimaera (NCT05197335)
- Testing
- Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws
- Where
- 8 sites in Italy
- Volunteers
- 206 people
- Sponsor
- Orthofix s.r.l.
Hip Fractures
Treatment of Sub-capital Fractures of Hip Joint by Using TriboFit™ Acetabular Buffer
The purpose of this study is to determine the performance and efficacy during 6 and 12 month post operation. 1. determine changes in patient pain level 2. determine changes in patient functionality 3.
- Trial name
- NCT00663468
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Phoenix Kinetics
Elbow Tendinopathy, Ankle Sprains
Hyaluronic Acid for Soft Tissue Injuries
Soft Tissue Adapted Biocompatible Hyaluronic Acid, or STABHA™, has demonstrated varying degrees efficacy in patients treated for common musculoskeletal tendinopathies and ligament injuries, such as ankle sprains, lateral elbow…
- Trial name
- SAFE (NCT05278897)
- Testing
- Soft Tissue Adapted Biocompatible Hyaluronic Acid
- Volunteers
- 200 people
- Sponsor
- Global Research Solutions
ACL Injury
FastThread Interference Screws
Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction.
- Trial name
- NCT04689061
- Testing
- Arthrex FastThread Interference Screw
- Where
- 2 sites in United States, Germany
- Volunteers
- 50 people
- Sponsor
- Arthrex, Inc.
ACL Injury
Effects of HMB Supplementation on Recovery Following ACL Surgery
The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL injury occurs participation in physical activity is compromised.
- Trial name
- NCT02602561
- Testing
- HMB
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Metabolic Technologies Inc.