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Interbody Systems: Post Market Clinical Follow-up Study | Clinical Trials | Clareo Health

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Interbody Systems: Post Market Clinical Follow-up Study

Multi Center, Prospective Evaluation for Clinical and Radiographic Outcomes Utilizing Stryker Spine Cervical and Lumbar Interbody Systems: Observational Post Market Clinical Follow up Study

NCT04911257•K2M, Inc.

View on ClinicalTrials.gov

Summary

This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF). The primary study hypothesis for each system is that the mean change in NDI (cervical) or ODI (lumbar) from baseline to Month 12 \< -10, that is, the mean improvement exceeds 10 points. In supporting analysis, the same hypotheses will be tested for mean change from baseline to 24 months to demonstrate durability of effectiveness.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•2. Diagnosed with degenerative disc disease (DDD).
•Please note for Lumbar devices:
•* Can also be diagnosed with up to Grade 1 Spondylolisthesis and/or Degenerative Scoliosis. (Chesapeake is not indicated for degenerative scoliosis)
•* Cascadia/Mojave/ Sahara/ Monterey AL can also be diagnosed with up to Grade 1 Retrolisthesis.
•Outside of USA, Tritanium is indicated for use in patients with diagnosis of Degenerative Spine Disorders, Spine Revision, Discal and Vertebral Instability; and there is no restriction to Spondylolisthesis Grade.
•3. Willingness and ability to comply with the requirements of the protocol including follow up requirements.
•4. Willing and able to sign a study specific informed consent form.
•5. Skeletally mature (age at least 18 years) and:
•1. Have had six months of lumbar non operative therapy.
•2. Have had six weeks of cervical non operative treatment.
+5 more criteria

Exclusion Criteria

•1. Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.
•2. For the Tritanium and Monterey AL systems: Any neuromuscular deficit which places an unsafe load on the device during the healing period.
•3. For the Cascadia, Chesapeake, Mojave and Sahara systems: Metabolic disorders of calcified tissues.
•4. Biological factors such as smoking or using nonsteroidal anti inflammatory agents/ anticoagulants.
•5. Immunosuppressive disorders.
•6. Grossly distorted anatomy. N/A for Tritanium TL, Tritanium Cervical and Monterey AL
•7. Inadequate tissue coverage or open wounds.
•8. Infection at index level(s) at the time of surgery.
•9. Patients with known sensitivity to materials in the device.
•10. Has a neuromuscular disorder or mental condition (including general neurological conditions, mental illness, senility, and drug/alcohol abuse) which would create an unacceptable risk of fixation failure or complications in postoperative care or willingness to restrict activities or follow medical advice.
+10 more criteria

Locations (4)

Spine Institute of Louisiana Foundation, Inc.

Shreveport, Louisiana, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Spine Clinic of Oklahoma City

Oklahoma City, Oklahoma, United States

Inova Neurosciences Research

Falls Church, Virginia, United States

Key Dates

Start Date

December 7, 2021

Primary Completion Date

February 12, 2025

Completion Date

March 21, 2025

Last Updated

April 18, 2025

Enrollment

ACTUAL participants

Conditions

Degenerative Disc Disease

Interventions

Cervical or Lumbar Spinal fusion

DEVICE

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

NCT07254806

Degenerative Disc Disease

View study

RECRUITINGNA

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

NCT05508360

Degenerative Disc DiseaseChronic Low-back Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Interbody Systems: Post Market Clinical Follow-up Study

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Real World Data Collection on the Synergy Disc