Background:Lumbar degenerative diseases often require Transforaminal Lumbar Interbody Fusion (TLIF), but complications such as non-union (pseudarthrosis) can occur, particularly in osteoporotic patients.Teriparatide, a recombinant human PTH analog, is hypothesized to improve spinal fusion by stimulating bone formation, making it a potential therapeutic agent for reducing complications.

Study Objectives:

Primary Objective: Compare spinal fusion rates at 6 months and 1 year postoperatively between a Teriparatide-treated group and a control group.

Secondary Objectives: Assess clinical outcomes (e.g., disability and pain scores), bone mineral density changes (via DEXA scans), mechanical complications, and any adverse events.

Study Design:

Type: Randomized controlled trial (RCT)

Duration: 24 months (12-month follow-up post-surgery)

Population: 100 patients undergoing TLIF for lumbar degenerative conditions, randomized equally into a study (teriparatide) group and a control group.

Methodology:

Intervention: The study group receives daily teriparatide (20 mcg subcutaneously) along with calcium and vitamin D3 supplementation. The control group receives only calcium and vitamin D3.

Monitoring Tools: CT scans, DEXA scans, and clinical questionnaires (ODI, VAS, SF-36, Roland-Morris Disability Questionnaire).

Outcome Measures:

Primary Endpoint: Spinal fusion rate, evaluated by CT scans using standard criteria.

Secondary Endpoints: Improvement in pain and functional scores, bone mineral density changes, and complication rates (e.g., screw loosening, cage subsidence).

Inclusion and Exclusion Criteria:

Inclusion: Patients aged ≥45 years undergoing single-level TLIF for degenerative spine diseases.

Exclusion: Prior lumbar surgeries, teriparatide use, and contraindications (e.g., hypercalcemia, Paget’s disease).

Data Analysis:

Primary Analysis: Fusion rate comparisons.

Secondary Analysis: Assessment of disability scores, complications, and adverse events using statistical models.

Expected Outcomes:

The study aims to demonstrate that teriparatide therapy significantly enhances spinal fusion rates and clinical outcomes while maintaining a favorable safety profile, potentially establishing it as a preferred treatment adjunct in TLIF surgeries.