Clinical trials: Foot & Ankle
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics
Sensorimotor Gait Disorder, Neurologic Ambulation Disorder
Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop
The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.
- Conditions
- Sensorimotor Gait Disorder, Neurologic Ambulation Disorder, Gait, Drop Foot, Poststroke Hemiparesis
- Trial name
- L300 (NCT01138995)
- Testing
- Ness L300, Ankle-foot orthosis
- Where
- 11 sites in United States
- Volunteers
- 197 people
- Sponsor
- Bioness Inc
Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs
Safety and Performance of PEEK Anchors in Extremities
Safety and performance of the study devices in extremities up to 12 months post-surgery
- Conditions
- Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- NCT03782298
- Testing
- Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
- Where
- 4 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Cerebral Palsy (CP)
Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and experience walking activity limitations that negatively…
- Trial name
- CP-AFOFC (NCT03756571)
- Testing
- Ankle Foot Orthoses-Footwear Combination, Traditional Solid Ankle AFO (TSAFO)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Seattle Children's Hospital
Elective Foot and Ankle Surgery.
Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing
The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing incision helps prevent infection and slow wound healing.
- Trial name
- PRP (NCT01639144)
- Testing
- PRP and PPP
- Where
- United States
- Volunteers
- 515 people
- Sponsor
- Gary M. Kiebzak, Ph.D.
Multiple Sclerosis
The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with…
- Trial name
- NCT01947582
- Testing
- Ankle foot orthosis
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Texas Southwestern Medical Center
Post-surgical Pain, Total Knee Arthroplasty
Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks
Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for lower extremity post-operative pain control, specifically for total knee arthroplasty and foot/ankle surgery, respectively.
- Conditions
- Post-surgical Pain, Total Knee Arthroplasty, Foot/Ankle Surgery, Catheterization for Postop Analgesia
- Trial name
- NCT02523235
- Testing
- ropivacaine 0.2%
- Where
- United States
- Volunteers
- 117 people
- Sponsor
- University of California, San Diego
Stroke
WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients
To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily…
- Trial name
- NCT01087957
- Testing
- WalkAide, Ankle-Foot Orthosis (AFO)
- Where
- 29 sites in United States
- Volunteers
- 495 people
- Sponsor
- Innovative Neurotronics
Arthritis, Rheumatoid Arthritis
Wright Foot & Ankle Post-Market Observational Study
WRIGHT FOOT \& ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device
- Conditions
- Arthritis, Rheumatoid Arthritis, Fracture, Trauma Injury
- Trial name
- NCT04118894
- Testing
- Foot and Ankle Devices
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Injuries, Injury Arm
Virtual Reality for Pain in Acute Orthopedic Injuries
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established…
- Conditions
- Injuries, Injury Arm, Injury;Sports, Injury, Knee
- Trial name
- NCT05552430
- Testing
- RelieveVRx
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital
Ankle Osteoarthritis, Healthy Ankles
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
Ankle osteoarthritis (OA) is a painful, progressive condition that can severely limit physical activity and reduce quality of life.
- Trial name
- RB/AFO (NCT03524729)
- Testing
- Rocker bottom shoe, Ankle foot orthosis, Standard walking shoe
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Ankle Fractures, Post-traumatic Osteoarthritis
Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage.
- Conditions
- Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle
- Trial name
- PRMRP-FPA2 (NCT04562896)
- Testing
- Custom Carbon Fiber Dynamic Orthosis (CDO)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Iowa
Equinus Contracture
The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Pilon Fractures
The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at the time of surgery for pilon fractures, will improve ankle range-of-motion and functionality.
- Trial name
- Botox (NCT02051933)
- Testing
- Botulinum toxin type A, sodium chloride
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Saphenous Nerve Block
Saphenous Nerve Block for Foot and Ankle Surgery
Patients undergoing foot and ankle surgery have the option of having a nerve block administered by their Anesthesiologist. The nerve block numbs the foot and results in less post-operative nausea and vomiting, and better pain…
- Trial name
- NCT02382744
- Testing
- Ultrasound Guidance, Ultrasound guidance + nerve stimulation
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Foot Injuries and Disorders
Ankle Foot Orthosis Comparative Effect
The proposed effort is designed to support evidence-based practice and optimal care by evaluating how the form, fit and function of two commercially available carbon fiber custom fit braces (Orthoses) influences outcomes…
- Trial name
- AFOCE (NCT03901053)
- Testing
- Reaktiv AFO, PhatBrace AFO
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Jason Wilken
Lower Extremity Surgery, Bunion
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
- Conditions
- Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion
- Trial name
- STRIDE (NCT04518462)
- Testing
- Exparel, Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 121 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Ankle Arthrodesis, Hindfoot Arthrodesis
Foot and Ankle Clinic Application for Liposomal Related Anesthetic
The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.
- Conditions
- Ankle Arthrodesis, Hindfoot Arthrodesis, Tibitalocalceal Arthrodesis
- Trial name
- NCT02586077
- Testing
- Exparel
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- OrthoCarolina Research Institute, Inc.
Traumatic Amputation of Lower Extremity
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds.
- Trial name
- NCT00869947
- Testing
- Powered ankle-foot prosthesis, No device
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Foot Deformities, Acquired, Disorder of Joint of Foot
A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
- Conditions
- Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot, Deformity of Bone
- Trial name
- NCT02161016
- Testing
- map3
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- RTI Surgical
Narcotic Consumption, Pain
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice.
- Conditions
- Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction
- Trial name
- NCT00950183
- Testing
- Iceman® Cold Therapy unit (djOrtho), Ice
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- OrthoCarolina Research Institute, Inc.