Comparison of outcome lumbar spine vertebral fusion surgery using Micro and Nano-textured Titanium Cage implant versus PEEK material cage implant

Assessment of lumbar fusion and its significance on functional outcome following the usage of Micro and Nano-textured Titanium Cages - A prospective single blinded randomized controlled pilot study trial comparing nanotextured Titanium cages versus PEEK cages. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089874

Enrollment

150

Registered

2025-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M995- Intervertebral disc stenosis of neural canal

Interventions

Intervention1: Spine fusion surgery using Titanium nano technology cage implant: One time surgical procedure of spine fusion surgery using pedicle screws and Titanium nano technology cage implants for

Eligibility

Inclusion criteria

Inclusion criteria: Subject is scheduled to undergo interbody spinal fusion surgery using either the nanotechnology titanium cage or PEEK cage in conjunction with local autograft and supplementation with a pedicle screw system The subject must in the investigators opinion be psychosocially mentally and physically able to fully comply with this protocol including the required follow-up visits and have the ability to understand and give written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects with previous lumbar fusion surgery. 2. Subject has inadequate tissue coverage over the operative site. 3. Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis. 4. Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.). 5. Subject has an active local or systemic infection. 6. Subject has a metal sensitivity/foreign body sensitivity. 7. Subject is morbidly obese, defined as a body mass index (BMI) greater than 45. 8. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study. 9. Subject is currently involved in another investigational drug or device study that could confound study data.

Design outcomes

Primary

Measure	Time frame
Assessment of lumbar spine fusionTimepoint: 3 months, 6 months and 12 months	—

Secondary

Measure	Time frame
Clinical improvement after spoine fusionTimepoint: 3 months, 6 months and 12 months	—

Countries

India

Contacts

Public ContactImtiaz Ghani

Room num 35, Spine surgery unit, Apollo main hospital, Greams lane, Thousand lights, Chennai, Tamilnadu-600006

imtiazghani@gmail.com09585232835

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026