Evaluation of the long-term safety and performance of Baguera® L, a lumbar disc prosthesis used in the treatment of symptomatic lumbar disc disease

Evaluation of the long-term safety associated with the implantation of the BAGUERA®L lumbar disc prosthesis:
Safety measured using the reported incidence and time to resolution of all complications and adverse events related to the medical device and/or procedure, including all surgical revisions peri-and post-operatively up to a least 4 years (4-8 years) post-operative.

Current secondary outcome measures as of 02/06/2023:

Long-term evaluation of the performance of the Baguera®L lumbar disc prosthesis with follow- up at up to at least 4 years (4 to 9 years) post-implantation by measuring the following parameters:
1. Pain measured using the patient's self-reported visual analogue scale (VAS) back and leg, completed pre-operatively, at the 1st PO FU (<6 months) post-operatively and at the last follow-up (4-9 years) post-surgery
2. Pain measured using the Japanese Orthopaedic Association (JOA) questionnaire at the pre- operative visit and at the 1st PO FU (<6 months) and 4-9 years post-operative.
3. Functional capacity assessment measured using the patient's self-reported Oswestry disability index (ODI) questionnaire at the last follow-up (4-9 years) post-operative
4. Quality of life in relation to health and patient satisfaction measured using the patient self- reported SF-12 questionnaire at the last follow-up 4-9 years post-operative
5. Evaluation of the lumbar mobility at the treated level and at L1-S1, by radiological assessment of the Range Of Motion (ROM) based on lateral X-ray images in flexion and extension at the 2nd PO FU (≥6 months) and at the last follow-up (4-9 years) post-operative.
6. Evaluation of disc height at the treated level and at the suprajacent level, measured using radiological assessment based on neutral lateral X-ray images at the preop-operative visit, the 1st PO FU (<6 months), the 2nd PO FU (≥6 months) and the last follow-up (4-9 years) post-operative.
7. Evaluation of the subsidence at the treated level and the listhesis, by radiological assessment based on X-ray images at the pre-operative visit, the 1st PO FU (<6 months), the 2nd PO FU (≥6 months) and the last follow-up (4-9 years) post-operative.
8. Pain medication and clinical and neurological evaluation measured at pre-operative visit, before discharge and at the 1st PO FU (<6 months), the 2nd PO FU (≥6 months) and the last follow-up (4-9 years) post-operative.
9. Retrospective evaluation of the surgical instruments used for implantation of the device

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Previous secondary outcome measures:

Long-term evaluation of the performance of the Baguera®L lumbar disc prosthesis with follow-up at up to at least 4 years (4 to 8 years) post-implantation by measuring the following parameters:
1. Pain measured using the patient's self-reported visual analogue scale (VAS) back and leg, completed pre-operatively, 6-12 weeks post-operatively and at the last follow-up (4-8 years) post-surgery
2. Pain measured using the Japanese Orthopaedic Association (JOA) questionnaire at the pre-operative visit and at 6-12 weeks, 1 and 4-8 years post-operative
3. Functional capacity assessment measured using the patient's self-reported Oswestry disability index (ODI) questionnaire at the last follow-up (4-8 years) post-operative
4. Quality of life in relation to health and patient satisfaction measured using the patient self-reported SF-12 questionnaire at the last follow-up 4-8 years post-operative
5. Lumbar mobility at the treated level measured using radiological assessment of lateral X-ray images in flexion and extension at 1 year and at the last follow-up (4-8 years) post-operative. Mobility is considered preserved if ROM ≥ 5°
6. Evaluation of disc height at the treated level measured using radiological assessment of X-ray images at 1 year and the last follow-up (4-8 years) post-operative. Disc height is considered preserved if the height (measured at anterior, middle and posterior vertebral endplates) is similar to the height of the superjacent non-pathological level
7. Pain medication and clinical and neurological evaluation measured using the VAS, ODI, SF12 and JOA questionnaires (as per standard practice, if available) with data collected retrospectively from the patients’ clinical files from pre-operative until the 1-year postoperative follow-up and during the last prospective visit
8. Retrospective evaluation of the surgical instruments used for implantation of the device in terms of safety and performance measured using device deficiencies and complications (if any) documented in the Complaint Reports at the time of the surgery