Clinical trials: Deformity
Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis
Tornier Perform™ Reversed Monopost Study
This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis, Correction of Functional Deformity, Fracture of the Humeral Head
- Trial name
- Monarch (NCT07764614)
- Testing
- Tornier Perform™ Reversed MonoPost
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Stryker Trauma and Extremities
Bone Deformity
Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
This is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical…
- Trial name
- ROSA (NCT03570606)
- Testing
- bone graft substitute
- Where
- 7 sites in United Kingdom
- Volunteers
- 220 people
- Sponsor
- Ceramisys Ltd
Knee Pain Chronic, Osteoarthritis, Knee
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
- Conditions
- Knee Pain Chronic, Osteoarthritis, Knee, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- NCT05787821
- Testing
- Total Knee Arthroplasty
- Where
- 16 sites in United States
- Volunteers
- 760 people
- Sponsor
- Zimmer Biomet
Rhematoid Arthritis, Osteo Arthritis of the Knee
Persona SoluTion PPS Femur PMCF
The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under…
- Conditions
- Rhematoid Arthritis, Osteo Arthritis of the Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis
- Trial name
- NCT07286513
- Testing
- Total knee arthroplasty
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Knee Deformity
Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy
The aim of this study is to obtain performance and safety data of the new investigational device, dual-part Adaptos®Ortho Wedge, for its intended use in orthopaedic surgery.
- Trial name
- NCT05570760
- Testing
- Adaptos®Ortho Wedge (bone grafting surgery), OWHTO without bone grafting, chronOS® Wedge (bone grafting surgery)
- Where
- 6 sites in Finland, Hungary
- Volunteers
- 87 people
- Sponsor
- Biomendex Oy
Knee Pain Chronic, Osteoarthritis
Persona Ti-Nidium Post-Market Clinical Follow-up
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
- Conditions
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- TKA (NCT04817969)
- Testing
- Zimmer Biomet Persona Ti-Nidium Total Knee System
- Where
- 7 sites in United States
- Volunteers
- 240 people
- Sponsor
- Zimmer Biomet
Chest Wall Deformity, Prominent Lower Rib Cage
Prospective Evaluation of Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis for Lower Anterior Thoracic Prominence
This prospective single-group study will evaluate anterior aesthetic rib cage remodeling with osteosynthesis (ARCO) in adults with anteroinferior rib prominence or deformity.
- Trial name
- NCT07813234
- Testing
- Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis, Chest CT and Spirometry Follow-up
- Where
- Colombia
- Volunteers
- 160 people
- Sponsor
- Research Inc
Disc Degeneration, Spinal Deformity
MDT-0123 Japan Study
The purpose of this clinical trial is to compare the efficacy and safety of this investigational device with autologous iliac bone graft (ICBG) in patients who are deemed to require bone fusion through spinal fixation at two…
- Trial name
- NCT07414745
- Testing
- MDT-0123, ICBG
- Where
- 14 sites in Japan
- Volunteers
- 140 people
- Sponsor
- Medtronic Spinal and Biologics
Ankle Arthrodesis or Arthroplasty, Hindfoot Fusion
A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.
This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product that is routinely used by surgeon as treatment for hindfoot and ankle disorders.
- Conditions
- Ankle Arthrodesis or Arthroplasty, Hindfoot Fusion, Ankle Deformity, Ankle Disease
- Trial name
- ASTRA (NCT07225751)
- Testing
- MagnetOs, Autograft
- Where
- 7 sites in United States
- Volunteers
- 126 people
- Sponsor
- Kuros Biosurgery AG
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device.
- Conditions
- Rotator Cuff Tears, Rheumatoid Arthritis Shoulder, Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus
- Trial name
- SiD (NCT05868148)
- Testing
- Shoulder iD™ Primary Reversed Glenoid
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Stryker Trauma and Extremities
Hallux Valgus Deformity
Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves
This study is looking to test a non-compressive semiconductor embedded ankle sleeve and sock for post hallux valgus correction surgery rehabilitation.
- Trial name
- NCT07422623
- Testing
- Semiconductor embedded ankle sleeve and sock
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- INCREDIWEAR HOLDINGS, INC.
Spinal Muscular Atrophy, Spine Deformity
Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA).
- Conditions
- Spinal Muscular Atrophy, Spine Deformity, Scoliosis
- Trial name
- PIERRE (NCT05866419)
- Testing
- ThecaFlex DRx System
- Where
- 21 sites in United States, Germany and 3 more
- Volunteers
- 90 people
- Sponsor
- Alcyone Therapeutics, Inc
Spinal Deformity, Spinal Degenerative Disorder
The Ailliance Post-Market Clinical Study
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months.
- Conditions
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma
- Trial name
- NCT05856370
- Testing
- Follow-up schedule: pre-operative baseline up to 24-months post-procedure
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Spinal and Biologics
Osteoarthritis of the Shoulder, Avascular Necrosis
Database Retrieval for the Comprehensive Shoulder
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products.
- Conditions
- Osteoarthritis of the Shoulder, Avascular Necrosis, Rheumatoid Arthritis, Prior Failed Revision
- Trial name
- NCT03409718
- Testing
- Biomet Comprehensive Shoulder System
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Knee Pain, Chronic Osteoarthritis
ROSA Total Knee Post Market Study EMEA
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data.
- Conditions
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities
- Trial name
- NCT04338893
- Testing
- Device: Persona Total Knee, Device: NexGen Total Knee, Device: Vanguard Total Knee
- Where
- 6 sites in Belgium, Germany and 3 more
- Volunteers
- 252 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease (DDD), Instabilities
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Trial name
- NCT05489822
- Testing
- VERTICALE® Cervical System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Silony Medical GmbH
Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases.
- Conditions
- Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis, Spinal Deformity, Spinal Degeneration
- Trial name
- PASS DEGEN (NCT04670536)
- Testing
- PASS LP implants, PASS DEGEN, PASS TULIP PRIME
- Where
- 4 sites in France
- Volunteers
- 77 people
- Sponsor
- Medicrea International
Shoulder Fractures, Shoulder Arthritis
Zimmer Biomet Shoulder Arthroplasty PMCF
The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty.
- Conditions
- Shoulder Fractures, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Deformity
- Trial name
- NCT04984291
- Testing
- Alliance Glenoid, Identity Stem
- Where
- 17 sites in United States, Japan and 1 more
- Volunteers
- 584 people
- Sponsor
- Zimmer Biomet
Knee Pain Chronic, Rheumatoid Arthritis
Cemented vs Cementless Persona Keel RCT
The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
- Conditions
- Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis
- Trial name
- NCT05630053
- Testing
- Cementless Persona Knee System, Cemented Persona Knee System
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Zimmer Biomet