Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||21 Years - 75 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Riverside Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Riverside Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Degenerative Disc Disease, Degenerative Scoliosis|
This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.
Experimental: Tritanium Posterior Lumbar Cage
Surgical placement of the Tritanium Posterior Lumbar Cage
Active Comparator: AVS PEEK UniLIF
Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage
Device: - Tritanium Posterior Lumbar Cage
Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
Device: - AVS UniLIF PEEK Posterior Lumbar Cage
Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.