Clinical trials: Foot and Ankle Arthrodesis
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
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.
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Foot Deformities
Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis
This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle…
- Trial name
- NCT06258499
- Testing
- BHA
- Sponsor
- Carmell Therapeutics Corporation
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of…
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle
- Trial name
- NCT04715139
- Testing
- Products listed in Group/Cohort Description
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft.
- Trial name
- NCT02879149
- Testing
- AUGMENT® Bone Graft, Standard of Care
- Where
- 26 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- BioMimetic Therapeutics
Ankle Fracture, Ankle Arthrodesis
Compression Therapy for Swelling Management Following Ankle Injury
After an injury or undergoing foot/ankle surgery, patients often experience swelling in the injured area. Under current standard of care, plaster casts are removed at six weeks and patients are put in a walking boot.
- Trial name
- NCT06772649
- Testing
- Compression sleeve
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Nova Scotia Health Authority
Post-traumatic Osteoarthritis, Unspecified Ankle and Foot, Localized, Primary Osteoarthritis of the Ankle and/or Foot
Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
The objective of this study is to prospectively evaluate the mid-term results and intraoperative and postoperative complication rate in patients who underwent double or triple arthrodesis using CCS screws.
- Trial name
- NCT02619838
- Testing
- Aptus CCS 5.0 or/and 7.0 screws
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Duke University
Foot and Ankle Disorders, Ankle Fusion, Osteotomy
Burst Biologics Foot and Ankle Registry
This prospective registry was designed as an observational study to ascertain how commercially available Burst Products are being used by foot and ankle surgeons performing procedures which involve bone grafting, as well as…
- Trial name
- NCT03077256
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Burst Biologics
Ankle Osteoarthritis
Ankle Osteoarthritis
Ankle osteoarthritis is a progressive degenerative joint disease that is characterized by severe pain, loss of autonomy, diminished health-related quality of life, functional disability and diminished physical ability to fulfill…
- Trial name
- AO-IFAB (NCT03157141)
- Testing
- Ankle arthrodesis, Total ankle replacement
- Where
- France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Ankle Arthrodesis, MTP Arthrodesis
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
Vitamin D is important for bone health and recent research has emphasized the importance of adequate vitamin D levels for bone healing, wound healing, and possibly preventing infections post-operatively.
- Trial name
- NCT04772196
- Testing
- Vitamin D3
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Prisma Health-Midlands
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft.
- Trial name
- NCT03998137
- Testing
- AUGMENT® Injectable Bone Graft, Standard of Care
- Volunteers
- 94 people
- Sponsor
- BioMimetic Therapeutics
Foot and Ankle Arthrodesis, Foot and Ankle Osteotomy
Foot and Ankle Arthrodesis or Osteotomy With Io-Fix Type Fixation
The recovery of foot and ankle arthrodesis and osteotomy is still plagued by the problem of delayed consolidation or even pseudo-arthrosis.
- Trial name
- NCT04812353
- Testing
- Follow-up of Io-Fix type fixation
- Where
- Belgium
- Volunteers
- 208 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Surgery, Foot Deformities
Induce XT™ Bone Graft in Foot and Ankle Fusion
The goal of this study is to evaluate how effective Induce XT is in patients undergoing foot and/or ankle surgery. Induce XT is a bone graft material used in surgeries to fill gaps where bone is missing, such as during foot and…
- Conditions
- Surgery, Foot Deformities, Ankle Arthropathy
- Trial name
- NCT06662266
- Testing
- Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- Red Rock Regeneration Inc.
Orthopedic Equine Varus Deformity
Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot
This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.
- Trial name
- talobot (NCT02790346)
- Testing
- arthrodesis talonavicular, tendon gestures
- Where
- France
- Volunteers
- 33 people
- Sponsor
- University Hospital, Montpellier
Tibiotalar Arthrodesis, Subtalar Arthrodesis
Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion
The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate.
- Conditions
- Tibiotalar Arthrodesis, Subtalar Arthrodesis, Calcaneocuboid Arthrodesis, Talonavicular Arthrodesis
- Trial name
- TAF (NCT00988338)
- Testing
- Trinity Evolution
- Where
- 10 sites in United States
- Volunteers
- 106 people
- Sponsor
- Orthofix Inc.
Arthritis
A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery
The current research study evaluates an investigational medical device called Amplex B2A(TM) Peptide Enhanced Ceramic Granules ("Amplex") for use in foot and ankle fusion. Amplex is a synthetic bone graft material.
- Trial name
- NCT01224119
- Testing
- Amplex, Autograft bone
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- BioSurface Engineering Technologies, Inc