Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants… (NCT06265038) | Clinical Trial Compass
RecruitingNot Applicable
Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
Hungary99 participantsStarted 2024-02-01
Plain-language summary
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.
The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:
* To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.
* To evaluate if implantation causes significant increase quality of life of the patients.
* To evaluate if using the device can be considered as safe overall.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L1 to S1), manifested by:
✓. Low back pain, or
✓. Irradiating leg or buttock pain, paresthesia, numbness, or weakness, or
✓. History of neurogenic claudication.
✓. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:
✓. Instability as defined by ≥3 mm translation or ≥5-degree angulation
✓. Decreased disc height, on average by ≥2 mm, but dependent upon the spinal level
✓. Scarring/thickening of ligamentum flavum or annulus fibrosis
Exclusion criteria
✕. Prior surgical procedure at the involved or adjacent spinal levels (e.g. stabilization, fusion, arthroplasty and/or other non-fusion procedures). Prior microdiscectomy, discectomy, laminectomy, decompression surgery at the target or adjacent levels is allowed.
What they're measuring
1
CT imaging_1 - cumulative fusion rate
Timeframe: At visit 4 (Month 24)
2
CT imaging_2 - fusion status
Timeframe: At visit 4 (Month 24)
Trial details
NCT IDNCT06265038
SponsorSanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.
✕. Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
✕. Planned use of an internal or external bone growth stimulator.
✕. Lumbar scoliosis \>30 degrees.
✕. Patients who had a previous diagnosis of osteoporosis with a Tscore of -2.5 or below in the last 12 months. If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA (dual x-ray absorptiometry) scan will need to be obtained.
✕. Morbidly obese, as defined by a Body Mass Index (BMI) \>40.
✕. Presence of active malignancy or prior history of malignancy (noninvasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
✕. Overt or active bacterial infection, either local to surgical space or systemic.