Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this observational post-marketing study is to provide additional information on the safety and effectiveness of Idysâ„¢ TLIF 3DTi at up to 24 months post transforaminal lumbar fusion in usual surgical practice.
The primary endpoint is to evaluate the effectiveness of the Idysâ„¢ TLIF (Transforaminal Lumbar Interbody Fusion) 3DTi (Porous Titanium additive manufacturing) by measuring the evolution of the rate of fusion during the postoperative period.
The secondary endpoints are to analyze the safety and the patient's benefit of the Idysâ„¢ TLIF 3DTi by evaluating several point of view:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spine fusion surgery with Clariance Idys TLIF 3DTi | Device | Posterior fusion of the lumbar spine with Clariance Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod). |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the Fusion rate | Evolution of the radiological assessment of bony fusion at 3 different time point | 6 months, 12 months, 24 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | To quantify and describe adverse events | Up to 24 months postoperatively |
| Evolution of the Patient Disability | Assessment, at different time points, of the disability using Oswestry Disability Index score (range 0 to 100 with zero corresponding to no disability and 100 corresponding to the maximum disability possible) |
Not provided
Inclusion Criteria:
English Speaking patients
Patient with skeletal maturity
Patient with
Surgical treatment with Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).
Exclusion Criteria:
Not provided
Not provided
Not provided
Patient who need fusion of spinal lumbar segments
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mukund Gundanna, Dr | Brazos Spine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazos Spine | College Station | Texas | 77845 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively |
| Evolution of the Patient Pain | Assessment, at different time points, of the pain using Visual Analogue Scale (range 0 to 10 with higher scores meaning a worse outcome) | Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively |
| Radiologic Outcomes - Evolution of the lordosis angles (degree) | Measurements, on x-rays at different time points, of the lordosis angle at pathological / implanted level and of the global lordosis angle between L1/S1 | Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively |
| Radiologic Outcomes - Evolution of the Intervertebral Height (mm) | Measurements, on x-rays at different time points, of the anterior and the posterior inter-vertebral height. | Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively |
| Radiologic Outcomes - Stability of the Idys TLIF 3DTi Device | Measurement ,on x-rays at different time points, of the anterior position of the Idys TLIF 3DTi device | 6 weeks, 6 months, 12 months and 24 months postoperatively |