Clinical trials: sponsored by Smith & Nephew, Inc.
Healthy
Human Participant Study of Prototype Non-medicated Multilayer Foam Dressings on Intact Skin
The purpose of this study is to evaluate two new prototype non-medicated multilayer foam dressings on healthy, intact skin. The study will find out how well two new prototype dressings stay in place as well as other dressing…
- Trial name
- NCT06700850
- Testing
- Prototype dressing rectangle, Marketed dressing rectangle, Prototype dressing square
- Where
- Germany
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Hip Osteoarthritis
OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study
The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation
- Trial name
- NCT02353377
- Testing
- OXINIUM DH Hip System, BIOLOX◊
- Volunteers
- 413 people
- Sponsor
- Smith & Nephew, Inc.
Meniscus Tear
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair…
- Trial name
- FAST-FIX FLEX (NCT04903106)
- Testing
- FAST-FIX FLEX Meniscal Repair System
- Where
- 5 sites in United States, Australia and 2 more
- Volunteers
- 63 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis of the Shoulder
TITAN™ Reverse Shoulder System
The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the…
- Trial name
- NCT02204228
- Testing
- TITAN™ Reverse Shoulder System (TRS)
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 151 people
- Sponsor
- Smith & Nephew, Inc.
Total Hip Arthroplasty (THA), Osteoarthritis
A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System
A Multi-Center Study in Patients Undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The purpose of the study is to assess safety and performance of the CATALYSTEM™ and to support product…
- Conditions
- Total Hip Arthroplasty (THA), Osteoarthritis, Degenerative Joint Disease, Inflammatory Arthritis
- Trial name
- CATALYSTEM (NCT06564636)
- Testing
- CATALYSTEM
- Where
- 10 sites in United States, Canada
- Volunteers
- 119 people
- Sponsor
- Smith & Nephew, Inc.
Arthroplasty, Replacement, Knee
Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
- Trial name
- ANTHEM PS (NCT03078543)
- Testing
- ANTHEM™ PS Total Knee System implant
- Where
- 8 sites in China, Italy and 3 more
- Volunteers
- 148 people
- Sponsor
- Smith & Nephew, Inc.
Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee
Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment…
- Trial name
- JII-Uni (NCT03768128)
- Testing
- Journey™ II UNI Unicompartmental Knee System
- Where
- 6 sites in United States, Italy and 1 more
- Volunteers
- 154 people
- Sponsor
- Smith & Nephew, Inc.
Meniscus Tear, Retention; Meniscus
Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint.
- Trial name
- NOVOSTITCH PRO (NCT04361487)
- Testing
- NOVOSTITCH™ PRO Meniscal Repair System
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- Smith & Nephew, Inc.
Total Knee Arthroplasty
Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts
The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past.
- Trial name
- Legion Oxinium (NCT03687593)
- Testing
- Legion™ CR Oxinium and CoCr Femoral Implants combined with Legion™/Genesis™ II XLPE High Flex Tibial Inserts
- Where
- 4 sites in United States
- Volunteers
- 126 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis
POLARSTEM Cementless Hip Stem
Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.
- Trial name
- POLARSTEM (NCT02648152)
- Testing
- Total Hip Arthroplasty
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 218 people
- Sponsor
- Smith & Nephew, Inc.
Venous Insufficiency, Venous Leg Ulcer
PICO Venous Leg Ulcers (VLU) Reimbursement Study
This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners.
- Trial name
- NCT06510777
- Testing
- PICO Treatment, Standard of Care (SOC) Treatment
- Where
- 44 sites in France
- Volunteers
- 142 people
- Sponsor
- Smith & Nephew, Inc.
Arthritis
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral…
- Trial name
- CHRA (NCT02405208)
- Testing
- PyroTITAN HRA
- Where
- 5 sites in Australia, France and 2 more
- Volunteers
- 156 people
- Sponsor
- Smith & Nephew, Inc.
Degenerative Joint Disease
Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™
LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component…
- Trial name
- NCT02380092
- Testing
- LEGION™ Primary TKS with VERILAST™ Bearing Surface
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 163 people
- Sponsor
- Smith & Nephew, Inc.
Cartilage or Osteochondral Defects in the Knee, Up to Moderate Osteoarthritis
Agili-C™ Implant Performance Evaluation
The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee.
- Trial name
- NCT03299959
- Testing
- Agili-C implant, SSOC
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 251 people
- Sponsor
- Smith & Nephew, Inc.
Arthroplasty, Replacement, Knee, Unicompartmental Knee Arthroplasty
Study to Evaluate Patient Outcomes and Safety and Effectiveness of Robotic Assisted Unicompartmental Knee Replacements Versus Conventional Unicompartmental Knee for Subjects With Primary Arthritis of the Knee Joint Involving One (UKA) Compartment (Medial or Lateral)
The overall aim of this trial is to compare functional and patient-reported outcomes and to assess the safety and effectiveness and long-term performance of the Smith+Nephew Robotic Systems for Unicompartmental Knee Replacements…
- Trial name
- NCT06036212
- Testing
- Robotic System, Conventional
- Where
- 5 sites in United Kingdom
- Sponsor
- Smith & Nephew, Inc.
Chronic Wounds, Acute Wounds
A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds
The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.
- Trial name
- NCT06306716
- Testing
- RENASYS Film with AIRLOCK Technology
- Where
- 2 sites in Canada, Puerto Rico
- Volunteers
- 7 people
- Sponsor
- Smith & Nephew, Inc.
Arthroplasty, Replacement
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures
Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery…
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- NCT04786119
- Testing
- CORI Robotics
- Where
- 8 sites in United States, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Smith & Nephew, Inc.
Arthroplasty, Replacement
Evaluate the Performance of JOURNEY II CR in TKA Populations
Background: The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II CR Total Knee System Objectives: Evaluate the…
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- JIICRTKA (NCT04818840)
- Testing
- Resurfaced Patella, Un-resurfaced Patella
- Where
- 8 sites in China, India and 3 more
- Volunteers
- 62 people
- Sponsor
- Smith & Nephew, Inc.
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Rotator Cuff Injuries
REGENETEN™ Bioinductive Implant System in Full-thickness Tears
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic…
- Trial name
- REGENETEN (NCT04450342)
- Testing
- Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation, Arthroscopic rotator cuff repair, Arthroscopic rotator cuff repair for revision surgery
- Where
- 30 sites in United States, Australia and 6 more
- Volunteers
- 119 people
- Sponsor
- Smith & Nephew, Inc.