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NCT Number: NCT06704919

Conduit Cages and Fibergraft BG Putty

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.

Recruiting

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Hernia Herniated Disc Intervertebral Disc Degeneration Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Rida Mitha

CONTACT

[email protected]

3147327092

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Have a radiograph-based diagnosis of degenerative disc disease, ruptured or herniated discs,
  • Pathology of the cervical or lumbar spine.
  • Pathology to be between C2-T1 in the cervical group.
  • Pathology to be between L2-S1 in the lumbar group.
  • Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.
  • Patients receiving the surgery/devices as standard of care prescribed by the treating physician.

Exclusion criteria

  • Patients < 18 years
  • BMI > 40 kg/m2 to be excluded
  • Patients with a bone density (DEXA) score of <2.0 to be excluded
  • 3 or more levels for ACDF or Lumbar interbody to be excluded
  • Patients with previous pseudoarthrosis or failed spondylodesis to be excluded
  • Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded

Treatment and study plan

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.

Primary outcomes

  1. Fusion

    Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

    We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.

Secondary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

    We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively

  2. Oswestry Disability Index

    Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

    We will have patients fill out validated tools for PROs to assess how the patient is doing

  3. SF-12

    Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

    We will have patients fill out validated tools for PROs to assess how the patient is doing

  4. Neck Disability Index

    Time frame: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

    We will have patients fill out validated tools for PROs to assess how the patient is doing

Study contacts

Contact information is provided by the study sponsor or research team.

Nitin Agarwal, MD

CONTACT

[email protected]

9085311947

Rida Mitha, MD

CONTACT

[email protected]

3147327092

Sponsors and collaborators

Lead sponsor

Nitin Agarwal

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

Assess Clinical and Radiographic Outcomes of Conduit Cages and Fibergraft in Cervical and Lumbar Procedures

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Nov 26, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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