Conduit Cages and Fibergraft BG Putty

NCT ID: NCT06704919

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2029-03-30

Brief Summary

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.

Conditions

Degenerative Disc Disease; Herniated Disc

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Use of conduit cages and fibergraft BG Putty

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Have a radiograph-based diagnosis of degenerative disc disease, ruptured or herniated discs,

3. Pathology of the cervical or lumbar spine.

4. Pathology to be between C2-T1 in the cervical group.

5. Pathology to be between L2-S1 in the lumbar group.

6. Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.

7. Patients receiving the surgery/devices as standard of care prescribed by the treating physician.

Exclusion Criteria

1. Patients < 18 years

2. BMI > 40 kg/m2 to be excluded

3. Patients with a bone density (DEXA) score of <2.0 to be excluded

4. 3 or more levels for ACDF or Lumbar interbody to be excluded

5. Patients with previous pseudoarthrosis or failed spondylodesis to be excluded

6. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

Nitin Agarwal

OTHER

Sponsor Role: lead

Responsible Party

Nitin Agarwal

Associate Professor, Neurosurgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nitin Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nitin Agarwal, MD

Role: CONTACT

Phone: 9085311947

Email: nitin.agarwal@upmc.edu

Rida Mitha, MD

Role: CONTACT

Phone: 3147327092

Email: mithar@upmc.edu

Facility Contacts

Rida Mitha

Role: primary

Other Identifiers

STUDY24040009

Identifier Type: -

Identifier Source: org_study_id