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

Baguera® L, a lumbar disc prosthesis used in the treatment of symptomatic lumbar disk disease. Long-term evaluation.

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13718770

Enrollment

Registered

2023-01-17

Start date

2021-12-15

Completion date

Unknown

Last updated

2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical treatment of patients suffering from symptomatic lumbar disc disease (SLDD) affecting one vertebral level between L3 and S1 Surgery

Interventions

Current interventions as of 02/06/2023: Data collection on consecutive 70 to 100 patients treated with Baguera® L by 2 surgeons between 2013 and 2018. Data collection will consist of retrospective

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 65 years, who have received one Baguera® L as per the IFU and who signed an Informed consent or Information letter.

Exclusion criteria

Exclusion criteria: 1. Contraindications as per IFU 2. Pregnant or breastfeeding women 3. Patients unable to give written consent, e.g. legally incapacitated

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

France, Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026