Conduit Cages and Fibergraft BG Putty

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Nitin Agarwal
Study ID
NCT06704919
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Use of conduit cages and fibergraft BG Putty — DEVICE
    Patients who require spine surgery under standard of care and meet the inclusion and exclusion criteria identified, will be recruited from clinic. Consent for participation in study will be signed at the same time as consent for surgery. All PROMs and scans will be done as standard of care and data will be obtained through chart review for this study.

Study Details

The Conduit cages are intended to restore the intervertebral height and to facilitate the intervertebral body fusion in the cervical and lumbar spine in skeletally mature patients with degenerative disc disease and instabilities at one or more levels of the spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have described the use of conduit cages in interbody fixation procedures, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, and instabilities at one to multilevel contiguous levels between C2-T1 and 1-2 contiguous levels between L2-S1 of the spine with accompanying radicular symptoms, ruptured or herniated discs, and pseudarthrosis and spondylodesis. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.

Key Dates

Start date
Nov 4, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Fusion [ Time Frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Rida Mitha
[email protected]
3147327092

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By research site
University of Pittsburgh Medical Center· Pittsburgh, PA

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