Clinical trials: sponsored by Stryker Trauma and Extremities
Arthroplasty, Hemiarthroplasty
A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites.
- Conditions
- Arthroplasty, Hemiarthroplasty, Shoulder Pain
- Trial name
- NCT04089371
- Testing
- ReUnion Total Shoulder Arthroplasty (TSA), ReUnion Reverse Shoulder Arthroplasty (RSA)
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Stryker Trauma and Extremities
Arthritis, Rheumatoid Arthritis
Wright Foot & Ankle Post-Market Observational Study
WRIGHT FOOT \& ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device
- Conditions
- Arthritis, Rheumatoid Arthritis, Fracture, Trauma Injury
- Trial name
- NCT04118894
- Testing
- Foot and Ankle Devices
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Neuropathy, Charcot; Disease (Etiology)
Lower Extremity Fixation In Neuropathic Patients Study
Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di…
- Trial name
- FINS (NCT04607044)
- Testing
- SALVATION™ EXTERNAL FIXATION
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Stryker Trauma and Extremities
Shoulder Arthroplasty
A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites.
- Trial name
- NCT03880955
- Testing
- ReUnion RSA System
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- Stryker Trauma and Extremities
Tibial Fractures
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled.
- Trial name
- NCT04015167
- Testing
- T2 Alpha Tibia Nailing System
- Where
- 4 sites in United States
- Volunteers
- 103 people
- Sponsor
- Stryker Trauma and Extremities
Primary Generalized (Osteo)Arthritis, Post-traumatic Arthrosis of Other Joints, Upper Arm
Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
- Trial name
- NCT01390038
- Testing
- Simpliciti™ Shoulder System
- Where
- 14 sites in United States
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Osteoarthritis, Avascular Necrosis
Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty
The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.
- Conditions
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
- Trial name
- PYC (NCT02525783)
- Testing
- Aequalis Pyrocarbon Humeral Head
- Where
- United States
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Orthopedics
Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)
The Surgeons Clinical Outcomes Registry (SCOR) is a global registry designed to collect safety and performance data on commercially available Wright Medical products.
- Trial name
- SCOR (NCT04032444)
- Where
- 7 sites in United States
- Volunteers
- 723 people
- Sponsor
- Stryker Trauma and Extremities
Diabetic Foot Ulcers
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
- Trial name
- NCT01353495
- Testing
- APM Graft (BIOTAPE XMTM), Wound Debridement
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- Stryker Trauma and Extremities
Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Aequalis Resurfacing Head Study
Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007.
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Trial name
- NCT02444299
- Testing
- Shoulder hemi-arthroplasty
- Volunteers
- 100 people
- Sponsor
- Stryker Trauma and Extremities
Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by…
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Trial name
- NCT02424760
- Testing
- Shoulder hemi-arthroplasty
- Volunteers
- 67 people
- Sponsor
- Stryker Trauma and Extremities
Femoral Neck Fractures, Intertrochanteric Fracture
Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation
The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures.
- Trial name
- INSITE (NCT01380444)
- Testing
- Gamma3 Intramedullary Nails (Stryker), Sliding Hip Screws
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 880 people
- Sponsor
- Stryker Trauma and Extremities
Shoulder Osteoarthritis
Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.
- Trial name
- NCT02452957
- Where
- Germany
- Sponsor
- Stryker Trauma and Extremities
Full Thickness Rotator Cuff Tear
BioFiber Scaffold Post-Market Observational Study
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
- Trial name
- NCT01849458
- Testing
- BioFiber
- Where
- 3 sites in United States, France
- Volunteers
- 50 people
- Sponsor
- Stryker Trauma and Extremities
Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis
Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair
The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.
- Conditions
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations
- Trial name
- CERAM (NCT02062437)
- Volunteers
- 132 people
- Sponsor
- Stryker Trauma and Extremities
Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture
- Trial name
- NCT02062450
- Testing
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Volunteers
- 379 people
- Sponsor
- Stryker Trauma and Extremities
Primary Arthrosis
Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients
The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle.
- Trial name
- STAR 8 (NCT01288586)
- Testing
- Scandinavian Total Ankle Replacement System (STAR Ankle)
- Where
- 5 sites in United States
- Volunteers
- 87 people
- Sponsor
- Stryker Trauma and Extremities
Arthrodesis, Degenerative Arthritis
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.
- Conditions
- Arthrodesis, Degenerative Arthritis, Rheumatoid Arthritis, Complications; Arthroplasty, Mechanical
- Trial name
- NCT01366989
- Testing
- Radiographic evaluation of previously implanted patients
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Stryker Trauma and Extremities
Hallux Limitus of Left Great Toe, Rheumatoid Arthritis
Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.
Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants.
- Conditions
- Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint, Osteoarthritis
- Trial name
- NCT02350881
- Testing
- Primus FGTI (Flexible Great toe Implant)
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Stryker Trauma and Extremities
Rotator Cuff Tear
Outcomes in Rotator Cuff Repair Using Graft Reinforcement
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
- Trial name
- NCT01025037
- Testing
- Conexa Reconstructive Tissue Matrix
- Where
- 6 sites in United States
- Volunteers
- 61 people
- Sponsor
- Stryker Trauma and Extremities