Performance and safety Clinical study on JULIET®TI LL cage in fusion lumbar spinal surgery

Phase 4

• Conditions: Patients with symptomatic degenerative lumbar disc diseases (DDD) and spondylosisthesis, functionally disabling discogenic low back pain that does not improve after conservative care; Musculoskeletal Diseases

• Registration Number: ISRCTN12002403
• Lead Sponsor: Spineart (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-12
• Last Update Posted: 4 March 2024
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Skeletally mature subjects, =18 years old
2. Indicated DDD defined as discogenic back pain with degeneration of the disc confirmed radiographically and by patient history
2.1. DDD, or
2.2. DDD with up to grade I Spondylolisthesis, or
2.3. DDD with up to grade I Retrolisthesis
3. Psychosocially, mentally, and physically able to fully comply with the protocol including adhering to follow-up schedule and filling out questionnaires.
4. Written voluntary informed consent signed

Exclusion Criteria

1. Mental illness
2. Infection
3. Severely damaged bone structures that could prevent stable implantation of the cage (bone density in SD =-2.5)
4. Neuromuscular or vascular disorders or illness
5. Inadequate activity (inability to follow postoperative rehab restriction)
6. Pregnancy
7. Bone tumor in the region of the implant
8. Fractures (same level treated or adjacent level: active, non-consolidated, or old osteoporotic fracture)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The interbody fusion performance of JULIET® Ti LL system measured by spine CT scan within 24 months postoperatively

Secondary Outcome Measures

Name	Time	Method
1. Subsidence assessed with standing neutral lateral x-rays at 3-, 6-, 12- and 24-months postoperative visits<br>2. Lordosis restoration and sagittal balance assessed with full spine x-ray/teleradiography of the spine at 12- and 24-month postoperative visits<br>3. Safety assessed using all perioperative and postoperative adverse device effects (ADE) and serious adverse events (SAEs)<br>4. Pain assessed using Visual Analogue Scale (VAS) Back and Leg pain scores at 3-, 6-, 12- and 24-months postoperative visits<br>5. Health-related quality of life assessed using the SF-12 health survey at 3-, 6-, 12- and 24-months postoperative visits<br>6. Low back disability assessed using Oswestry Disability Index (ODI) disease-specific questionnaire at 3-, 6-, 12- and 24-months postoperative visits<br>7. Patient satisfaction assessed using questionnaire at 3, 6, 12 and 24 months postoperative visits<br>8. Safety and performance of the instrumentation supporting the surgery assessed using questionnaire at time of surgery