Clinical trials: Lower Extremity Performance
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Fractures, Bone, Fractures, Closed
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the…
- Conditions
- Fractures, Bone, Fractures, Closed, Fractures, Open, Fracture of Femur
- Trial name
- NCT06400732
- Testing
- Fitbone Transport and Lengthening System
- Where
- 9 sites in United States
- Volunteers
- 1 people
- Sponsor
- Orthofix Inc.
Acquired Brain Injury (Including Stroke), Spinal Cord Injury
Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair…
- Conditions
- Acquired Brain Injury (Including Stroke), Spinal Cord Injury, Multiple Sclerosis
- Trial name
- NCT07550699
- Testing
- ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES)
- Where
- Austria
- Volunteers
- 14 people
- Sponsor
- ABLE Human Motion S.L.
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Trial name
- SWING (NCT04107298)
- Testing
- SUNDANCE™ Drug Coated Balloon
- Where
- 8 sites in Australia, Austria and 3 more
- Volunteers
- 35 people
- Sponsor
- SurModics, Inc.
Leg Ulcer
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to…
- Trial name
- NCT01591434
- Testing
- AQUACEL®, AQUACEL® Extra™
- Where
- 12 sites in Germany, Netherlands and 2 more
- Volunteers
- 65 people
- Sponsor
- ConvaTec Inc.
Knee Sprain (Mild), Knee Sprain (Moderate)
Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
Decathlon has developed kneeMID500-STRONG700 products which are two medical devices designed to be used for sport resumption after mild (kneeMID500) or moderate (KneeSTRONG100) knee sprain or after an Anterior Cruciate Ligament…
- Conditions
- Knee Sprain (Mild), Knee Sprain (Moderate), Anterior Cruciate Ligament Tear
- Trial name
- NCT04592471
- Testing
- kneeMID500-STRONG700
- Where
- 2 sites in France
- Volunteers
- 60 people
- Sponsor
- Decathlon SE
Pressure Ulcer, Arterial Ulcers
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected…
- Conditions
- Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer, Diabetic Ulcers
- Trial name
- NCT05646121
- Testing
- Suprasorb® A + Ag wound dressing and rope
- Where
- 8 sites in Poland
- Volunteers
- 99 people
- Sponsor
- Lohmann & Rauscher
Knee Injuries and Disorders, Shoulder Disease
C Scope Visualization System Prospective Study
Evaluation of the performance and safety of the C Scope Visualization System
- Conditions
- Knee Injuries and Disorders, Shoulder Disease, Shoulder Injuries
- Trial name
- NCT05153863
- Testing
- C Scope Visualization System
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- CIT Ortho
Sarcopenia
Clinical Trial to Evaluate the Efficacy of Neuromuscular Electrical Stimulation Therapy in Patients With Sarcopenia
The goal of this clinical trial is to exploratorily evaluate the safety and efficacy of a home-based lower extremity muscle strengthening and physical performance enhancement program using Neuromuscular Electrical Stimulation…
- Trial name
- NMES (NCT07668258)
- Testing
- neuromuscular electrical stimulation
- Volunteers
- 40 people
- Sponsor
- Exosystems
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Venous Leg Ulcer
Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study…
- Trial name
- NCT05873257
- Testing
- Biatain Fiber Ag applied to participants
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Coloplast A/S
Chronic Ulcer of Leg or Foot, Pressure Injury
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
- Trial name
- MORGEN (NCT05632250)
- Testing
- ConvaFoam
- Where
- 5 sites in United States
- Volunteers
- 95 people
- Sponsor
- ConvaTec Inc.
Acquired Brain Injury (Including Stroke)
Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting.
- Trial name
- NCT07050875
- Testing
- ABLE Exoskeleton
- Where
- 3 sites in Spain
- Volunteers
- 14 people
- Sponsor
- ABLE Human Motion S.L.
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB
Hip Disease, Hip Fractures
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real…
- Trial name
- ESOP2 (NCT04193163)
- Testing
- Hip prosthesis - ESOP 2 cementless femoral stem
- Where
- 7 sites in France
- Volunteers
- 10 people
- Sponsor
- FH ORTHO
Wound Heal, Wound; Foot
Management of Acute and Chronic Wounds With Hyaluronic Acid
The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the…
- Trial name
- NCT06108999
- Testing
- Connettivina BIO cream and gauze
- Where
- 3 sites in Italy
- Volunteers
- 170 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Venous Leg Ulcer (VLU)
An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers
This is a pharmacokinetics (PK) study - the main objective of this study is to assess the PK, safety and clinical performance of 5% EscharEx (EX-03 formulation) in debridement of Venous Leg Ulcers
- Trial name
- NCT07692178
- Testing
- EX-03
- Volunteers
- 20 people
- Sponsor
- MediWound Ltd
Osteoarthritis, Hip, Rheumatoid Arthritis
Exception Cementless Hip Stem
This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Congenital Hip Dysplasia
- Trial name
- Exception (NCT04349046)
- Testing
- Total hip arthoplasty (THA)
- Where
- 6 sites in Belgium, France
- Volunteers
- 332 people
- Sponsor
- Zimmer Biomet
Knee Ligament Injury
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications.
- Trial name
- NCT04076956
- Testing
- Anterior Cruciate Ligament Reconstruction
- Where
- France
- Volunteers
- 55 people
- Sponsor
- Biomatlante