Neck Pain Clinical Trial
Official title:
First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. The study consists of a screening period, surgical procedure, and 6 post-operative visits. At each indicated visit, quality of life scales and adverse events will be collected. In addition, at 4 weeks post-operatively, patients will undergo static lateral cervical plain x rays to assess implant positioning and integrity. At 3 months, 6 months, 12 months, 18 months, and 24 months, patients will undergo flexion/extension and neutral lateral plain radiographs to assess overall success and fusion. The study has co-primary endpoints for efficacy (fusion) and overall success where overall success is defined as fusion, device implanted as intended, no serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions. Fusion data will be compared to benchmark data (Davis et al, 2013, control arm of the 2-level Mobi-C IDE study). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05293847 -
Postural Based Telerehabilitation in Mechanic Neck Pain
|
N/A | |
Completed |
NCT04060004 -
The Effects of Dry Needling on the Superficial Neck Musculature
|
N/A | |
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Active, not recruiting |
NCT05870371 -
The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain
|
N/A | |
Completed |
NCT06049316 -
Scapular Stabilization vs Functional Exercises on Chronic Neck Pain
|
N/A | |
Recruiting |
NCT05944354 -
Wearable Spine Health System for Military Readiness
|
||
Completed |
NCT02882061 -
Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain
|
N/A | |
Completed |
NCT02731014 -
Dry Needling for Patients With Neck Pain
|
N/A | |
Completed |
NCT02904668 -
Self-management Program in Chronic Neck Pain
|
N/A | |
Completed |
NCT03147508 -
Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.
|
||
Completed |
NCT02638987 -
EMG Activity Before, During and After Dry Needling
|
N/A | |
Active, not recruiting |
NCT02843269 -
Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Completed |
NCT02245425 -
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
|
N/A | |
Completed |
NCT02225873 -
The Effectiveness of Exercises Protocol in Management of Neck Pain
|
N/A | |
Completed |
NCT02235207 -
Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain
|
N/A | |
Completed |
NCT02190890 -
Dry Needling Dosage in the Treatment of Myofascial Neck Pain
|
N/A | |
Completed |
NCT02051478 -
Thoracic Manipulation and Mobilization for Neck Pain
|
N/A | |
Completed |
NCT01938209 -
A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain
|
N/A | |
Completed |
NCT01205542 -
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
|
N/A |