Clinical trials: sponsored by 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.
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.
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.
Otitis Media With Effusion, Acute Otitis Media
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure…
- Conditions
- Otitis Media With Effusion, Acute Otitis Media, Otitis Media
- Trial name
- NCT05915078
- Testing
- Iontophoresis and tube placement
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis, Knee
Safety and Efficacy of the Journey II BCS Total Knee System
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.
- Trial name
- NIMBLE (NCT01705067)
- Testing
- TKA with Journey II BCS Total Knee System
- Where
- 12 sites in United States
- Volunteers
- 209 people
- Sponsor
- Smith & Nephew, Inc.
Arthroplasties, Hip Replacement
REDAPT Retrospective-Prospective Modular Stem Study
A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market…
- Trial name
- NCT02661620
- Testing
- REDAPT Revision Femoral System modular stem
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Journey II CR Total Knee System
Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)
The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.
- Trial name
- JIICR (NCT03885531)
- Testing
- Total knee arthroplasty with Journey II CR Total Knee System
- Where
- 6 sites in United States
- Volunteers
- 586 people
- Sponsor
- Smith & Nephew, Inc.
Septoplasty
Safety and Performance of ENTACT Septal Staple System for Septoplasty
This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects.
- Trial name
- NCT04392583
- Testing
- ENTACT Septal Staple system
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Bankart Lesion, Acetabular Labrum Tear
S&P of Q-Fix™ All-Suture Anchor System
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
- Conditions
- Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain
- Trial name
- NCT03594071
- Testing
- The Q-Fix™ All-Suture Anchor
- Where
- 5 sites in United States
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Journey II BCS Total Knee System
Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
- Trial name
- JIIPROMS (NCT03903731)
- Testing
- Total knee arthroplasty with Journey II BCS Total Knee System
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 600 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis, Hip
Mini Stem Radiostereometric Analysis Study
The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device.
- Trial name
- MISRSA (NCT01064531)
- Testing
- MIS Femoral Neck Stem implant
- Where
- Canada
- Volunteers
- 41 people
- Sponsor
- Smith & Nephew, Inc.
Degenerative Arthritis of Knee
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched…
- Trial name
- NCT01084772
- Testing
- VISIONAIRE Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Where
- 7 sites in United States, Australia
- Volunteers
- 134 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis, Hip
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations.
- Trial name
- MISDexa (NCT01066936)
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis
Five and Ten Year Results of the CMK21 Hip System
Five and ten year results of the CMK21 Hip system
- Trial name
- CMK21 (NCT03908151)
- Testing
- CMK21 Hip system
- Where
- 2 sites in Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Total Knee Arthroplasty
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
- Trial name
- NCT03292003
- Testing
- Journey II BCS Total Knee System
- Where
- 12 sites in United States, Belgium and 1 more
- Volunteers
- 1,694 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Wounds and Injuries, Burns
Treatment of Wounds With a New Adhesive Foam Dressing
This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods. Patients will be treated with ELECT for 14 days.
- Trial name
- NCT02807584
- Testing
- ELECT
- Where
- South Africa
- Volunteers
- 25 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis, Hip, Arthritis, Degenerative
A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres (HISTORIC)
This is a retro-prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in at least 156 subjects, at up to 10 sites in Australia, who have been implanted with the EMPERION™ Modular…
- Trial name
- HISTORIC (NCT02435420)
- Testing
- EMPERION Modular Primary Stem
- Where
- 8 sites in Australia
- Volunteers
- 25 people
- Sponsor
- Smith & Nephew, Inc.
Total Knee Replacement Revision
LEGION™ Revision Metal Hypersensitivity Study
This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).
- Trial name
- NCT02412813
- Testing
- LEGION OXINIUM, LEGION Cobalt Chrome
- Where
- 3 sites in United States, Canada
- Sponsor
- Smith & Nephew, Inc.