Conduit Cages and Fibergraft BG Putty

Recruiting

• Conditions: Degenerative Disc Disease; Herniated Disc

• Registration Number: NCT06704919
• Lead Sponsor: Nitin Agarwal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Status Verified: 2024-11
• Study Start: 2024-11-04
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-26
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2028-12-31
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion	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 Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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
Oswestry Disability Index	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
SF-12	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
Neck Disability Index	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

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States