Clinical trials: Ankle Surgery
Surgery, Edema
Foot and Ankle Post-operative Oedema Management Using Geko™
The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess…
- Trial name
- NCT04927234
- Testing
- geko™ therapy
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 123 people
- Sponsor
- Firstkind Ltd
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.
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
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
Degenerative and Traumatic Pathology of the Knee, Degenerative and Traumatic Pathology of the Shoulder and Elbow
Web Based Orthopaedic Sports Medicine Registry
The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent…
- Conditions
- Degenerative and Traumatic Pathology of the Knee, Degenerative and Traumatic Pathology of the Shoulder and Elbow, Degenerative and Traumatic Pathology of the Foot and Ankle, Degenerative and Traumatic Pathology of the Hand and Wrist
- Trial name
- NCT01191151
- Where
- 258 sites in United States, Canada and 3 more
- Volunteers
- 12,500 people
- Sponsor
- Arthrex, Inc.
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 Fracture Requiring Internal Fixation
Midds Ankle Fracture
The geko™ device is indicated for the prevention and treatment of oedema. The aim of this study is to show that recruiting, and performing study assessments in ankle fracture patients requiring surgery to fix their ankle…
- Trial name
- NCT02841007
- Testing
- geko neuromuscular electrostimulation device
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Firstkind Ltd
Arthritis Foot, Trauma Injury
Artoss Foot and Ankle Surgery Registry
This prospective registry was designed as an observational study to ascertain how commercially available NanoBone products are being used by surgeons performing foot and ankle surgery which involves bone grafting, as well as…
- Conditions
- Arthritis Foot, Trauma Injury, Deformity; Bone
- Trial name
- ARK (NCT04503759)
- Testing
- NanoBone Bone Graft Substitute
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- Artoss Inc.
Knee Arthroplasty
Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients
The aim of this observational study is to assess whether patient reported pain levels correlate with a Pain Index derived from deviations in multivariate physiology biomarkers captured in real-world setting.
- Trial name
- ObservePAIN (NCT03789630)
- Testing
- Continuous physiology monitoring in ambulatory setting pre and post surgery
- Where
- Singapore
- Volunteers
- 55 people
- Sponsor
- Biofourmis Singapore Pte Ltd.
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
Surgery
Inion OTPS Biodegradable Fixation System for the Ankle
The purpose of the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.
- Trial name
- NCT00300989
- Testing
- Inion OTPS Biodegradable Fixation System
- Where
- Finland
- Volunteers
- 43 people
- Sponsor
- Inion Oy
Bunion, Metatarsophalangeal Fusion
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
- Conditions
- Bunion, Metatarsophalangeal Fusion, Midfoot Fusion, Hindfoot Fusion
- Trial name
- STRIDE (NCT03954639)
- Testing
- EXPAREL 13.3Mg/mL Suspension for Injection, Bupivacaine Hydrochloride
- Sponsor
- Pacira Pharmaceuticals, Inc
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.
Arthrodesis Surgery Involving the Hindfoot or Ankle
AMPLEX Ankle Fusion and Hindfoot
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
- Trial name
- NCT03028415
- Testing
- AMPLEX, Autogenous Bone Graft (ABG)
- Where
- 36 sites in United States, Canada
- Volunteers
- 56 people
- Sponsor
- Ferring Pharmaceuticals
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
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.
Tendinopathy, Tendon Tear
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair surgery.
- Conditions
- Tendinopathy, Tendon Tear, Tendon Injuries, Foot Ankle Injuries
- Trial name
- NCT03307499
- Testing
- NeoPatch
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- CryoLife, Inc.