Clinical trials: completed, sponsored by Smith & Nephew, Inc.
Non-inflammatory Degenerative Joint Disease
Journey™ UNI Post Market Clinical Follow-Up
This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.
- Trial name
- Journey UNI (NCT03442231)
- Testing
- Journey UNI Unicompartmental Knee System
- Where
- 4 sites in United States, Canada
- Volunteers
- 131 people
- Sponsor
- Smith & Nephew, Inc.
Labral Tear, Glenoid, Acetabular Labrum Tear
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors…
- Conditions
- Labral Tear, Glenoid, Acetabular Labrum Tear, Bankart Lesions, Anterior Shoulder Instability
- Trial name
- NCT03985839
- Testing
- MICRORAPTOR™ REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless PEEK Suture Anchor
- Where
- 12 sites in United States
- Volunteers
- 298 people
- Sponsor
- Smith & Nephew, Inc.
Arthroplasty, Replacement
To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- NCT04849884
- Testing
- CORI™ KNEE TENSIONER
- Where
- 4 sites in United States
- Volunteers
- 77 people
- Sponsor
- Smith & Nephew, Inc.
Healthy
Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin.
The purpose of this study is to evaluate a new prototype multilayer foam dressing on healthy, intact skin. The study will find out how well the new prototype dressing stays in place as well as other dressing performance and…
- Trial name
- NCT06831448
- Testing
- Prototype dressing, Marketed dressing 1, Marketed dressing 2
- Where
- Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Rotator Cuff
Safety of Treatment of Shoulder Repair
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
- Trial name
- HEALICOIL_KNTL (NCT04552119)
- Testing
- HEALICOIL Knotless PEEK, HEALICOIL Knotless REGENESORB
- Where
- 5 sites in United States
- Volunteers
- 138 people
- Sponsor
- 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.
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
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.
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.
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
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.
Degenerative Joint Disease
R3 Delta Ceramic Acetabular System PAS U.S.
R3 Delta Post-Approval Study U.S.
- Trial name
- R3-PAS (NCT03056534)
- Testing
- R3 Biolox Delta Ceramic Acetabular System
- Where
- 8 sites in United States
- Volunteers
- 189 people
- Sponsor
- Smith & Nephew, Inc.
Cruciate Ligament Reconstruction, Knee
Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
The objective of this study is to compare the safety and effectiveness of Biosure Regenesorb Interference Screw versus BIOSURE HA Interference Screw (control device) in patients requiring reconstruction of cruciate ligaments of…
- Trial name
- NCT04012567
- Testing
- Investigational device: Biosure Regenesorb Interference Screw, Control device: BIOSURE HA Interference Screw
- Where
- 4 sites in China
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.
Arthritis, Degenerative
Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System
The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.
- Trial name
- NCT02154516
- Testing
- ODH Hip System
- Where
- 2 sites in South Africa
- Volunteers
- 26 people
- Sponsor
- Smith & Nephew, Inc.
Arthritis
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™…
- Trial name
- HRA (NCT02983292)
- Testing
- PyroTITAN™ HRA
- Where
- Australia
- Volunteers
- 137 people
- Sponsor
- Smith & Nephew, Inc.
Soft Tissue to Bone Fixation
PMCF Study on PEEK Suture Anchors for Hip Indications
Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.
- Trial name
- NCT03814044
- Testing
- PEEK Suture Anchors
- Where
- 4 sites in United States
- Volunteers
- 149 people
- Sponsor
- Smith & Nephew, Inc.
Total Knee Arthroplasty, Arthroplasty of Knee
Navio With Total Knee Arthroplasty
The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments.
- Trial name
- NCT03317834
- Testing
- Navio ™ Robotic-assisted Surgical System
- Where
- 6 sites in United States
- Volunteers
- 122 people
- Sponsor
- Smith & Nephew, 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.
Pressure Ulcer, Leg Ulcer
Evaluation Of An Advanced Borderless Dressing
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
- Conditions
- Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03146845
- Testing
- ALLEVYN Life Non-Bordered, Standard Care
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.