Conduit™ Interbody Platform /EIT Cellular Titanium® Depuy Synthes Spine Clinical Registry

Overview

About this study

The purpose of this registry is to assess the clinical safety and performance of Conduit™ Interbody Platform /EIT Cellular Titanium® (Conduit/EIT) in subjects who undergo interbody fusion surgery.   

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subjects who have planned spinal fusion surgery with Conduit/EIT cages for any indications listed below:
    • For Conduit/EIT LLIF, PLIF, ALIF, and Curved TLIF cages, degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1;
    • For Conduit/EIT cage, cervical disc degeneration and/or cervical spinal instability, at one or multiple contiguous levels from C2 - T1.
  • Skeletally mature subjects at least 18 years of age at the time of consenting.
  • Subjects had at least six (6) months of non-operative treatment prior to treatment with a lumbar intervertebral cage.
  • Willing to provide voluntary written informed consent prior to participation in the registry.

Exclusion Criteria:

  • Subjects who had previous fusion surgery at the index level(s).
  • Subjects who have demonstrated allergy or foreign body sensitivity to the implant material.
  • Pregnant subjects.
  • Diagnosed with severe osteoporosis or osteopenia which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.
  • Diagnosed with severe instabilities, vertebral fractures, spinal tumors.
  • Subjects who have a systemic or metabolic disease which, in the PI’s opinion, would compromise their health, safety, or ability to participate or follow-up in this registry.
  • Conditions that may place excessive stress on the subject’s bone and implants, such as severe obesity. Severe obesity defined as BMI > 40 kg/m^2.
  • Subjects have any acute or chronic systemic, spinal, or localized infections.
  • Any medical or surgical condition precludes the potential benefit of spinal surgery, in the opinion of the PI.
  • Dependency on pharmaceutical drugs, drug abuse, or alcoholism resulting in a lack of subject cooperation.
  • Unable to return for a required minimum 12-month follow-up visit.
  • Unable to comply, and/or in the PI’s opinion unable to comply, with the requirements of participation in the registry.

Eligibility last updated 10/21/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Arjun Sebastian, M.D.

Open for enrollment

Contact information:

Zachary Pohlkamp

(507) 422-6831

Pohlkamp.Zachary@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20570320

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