Lumbar Disc DegenerationNCT06989632
Total Lumbar Disc Prosthesis and Subsequent Work Activity at at Least Five Years After Total Lumbar Disc Replacement
An observational study of Lumbar Disc Degeneration and Lumbar Disc Disease, run by University of Valencia at 1 site in Spain.
Trial summary
Lumbosciatica is a very prevalent pathology. When conservative treatments fail, surgery should be considered. The traditional surgical treatment is lumbar arthrodesis. The vast majority of patients who undergo spinal fusion cannot return to their same job and a good number of them never work again. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Degeneration, Lumbar Disc Disease, Sciatica
- What is being tested?
- Total lumbar disc prosthesis (Baguera®L, Spineart, Switzerland)
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2008to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic lumbar degenerative disc herniation and/or lumbar disc herniation that underwent a total lumbar disc replacement
Who may be able to join
- Age over 18 years with symptomatic lumbar degenerative disc herniation and/or lumbar disc herniation.
Who cannot join
- Any patient who BEFORE the implantation of a complete lumbar disc prosthesis had undergone any other type of surgical intervention on the lumbar spine. In particular, patients who had previously undergone a discectomy, whatever its form, or a spinal arthrodesis, whatever its technique, will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46015
About this study
Official title: Total Lumbar Disc Prosthesis and Subsequent Work Activity 5 Years After Total Lumbar Disc Replacement
Lumbosciatica is a very prevalent pathology. When conservative treatments fail, surgery should be considered. The traditional surgical treatment is lumbar arthrodesis. The vast majority of patients who undergo spinal fusion cannot return to their same job and a good number of them never work again. Another form of treatment for lumbosciatica is the implantation of a lumbar disc prosthesis. This technique preserves the mobility of the lumbar area that has been operated on. This allows for a greater return to work and a higher percentage of those who return to the same job. This study aims to quantify how many of the patients who have had a lumbar disc prosthesis implanted in the last twenty years have returned to their same job, how many have had to change their jobs, and how many have not returned to work and are now totally or completely disabled from work.
Read the detailed description
Low back pain is one of the most prevalent pathologies in the world population and one of the most frequent causes of temporary and permanent work incapacity, particularly in today's largely sedentary society.
Although its etiology is broad, degenerative disc disease, herniated disc, and osteoarthritis of the facet joints are its most common causes.
Conservative treatments resolve many cases, but when they are not effective, surgical options must be considered. These can be classified into two groups: those involving vertebral fusion with loss of mobility at the level or levels in question and those attempting to preserve it.
In lumbar disc herniation, the classic treatment, discectomy, consists of more or less completely removing the nucleus pulposus through a relatively small posterior annulotomy. This causes a loss of height of the intervertebral disc and the foramina and overload of the articular facets, which over time can be accompanied by arthritic changes and trigger chronic lumbar pain.
In the degeneration of the intervertebral disc and the osteoarthritis of the articular facets, the traditional surgical technique is the arthrodesis of the vertebral segment or segments causing the symptoms. The immobilization of the painful spinal area limits the progression of the foraminal stenosis and the overload of the articular facets of the level or levels operated on. However, the fusion alters the biomechanics of the spine, causing the overload of the adjacent vertebral segments with degeneration and osteoarthritis of these, which is the cause of chronic pain. It is not uncommon that, over the years, reintervention is required to extend the arthrodesis. In turn, a larger area of fused spine will cause more overload of the adjacent levels, which will also suffer the same process of degeneration and arthrosis mentioned above, thus creating a vicious circle.
The initial step of fusion of the painful joint has also been followed in the spine in the attempt to preserve mobility by implanting a complete prosthesis of the intervertebral disc, provided that there is no degeneration or arthrosis of the articular facets. It is an option to consider compared to arthrodesis of the same segment with the appropriate surgical technique (posterolateral arthrodesis, PLIF, TLIF, X-LIF, ALIF, OLIF, 360º lumbar arthrodesis, etc.).
Studies comparing lumbar arthrodesis and arthroplasty indicate that complete lumbar disc prostheses provide a better quality of life, better control of lumbar and radicular pain symptoms, an earlier return to work, a lower incidence of adjacent level syndromes, and a lower number of complications and reinterventions. These differences are most noticeable during the first year after surgery, disappear after two years, and reappear after five years, due to the appearance of adjacent level syndrome. However, we have been able to find in the scientific literature after a thorough search which of the two surgical techniques, arthrodesis or arthroplasty at the lumbar level, achieves a greater return to the same job, or even if there are differences in terms of the work activity that each of the two surgical techniques allows. The objective of the present study is to first analyze in patients with complete lumbar disc prosthesis the percentage of return to the same job, of work activity even if it is in another job, if there is a change of work activity to what type it is changed and finally the percentage of patients who are left with work disability, of what kind and with what degree of disability. To compare with lumbar arthrodesis is not possible at this time because the arthrodesis technique, unlike arthroplasty, is very variable according to the surgeons on the team, and in our Institution, it is not possible to obtain retrospectively a homogeneous group with which to compare.
- Conditions
- Lumbar Disc Degeneration, Lumbar Disc Disease, Sciatica, Lumbar Disc Herniation, Lumbar Degenerative Disease
- Being tested
- Total lumbar disc prosthesis (Baguera®L, Spineart, Switzerland)
- Keywords
- Chronic low back pain, Total lumbar disc replacement, Total lumbar disc arthroplasty, Sciatica
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral disc disease, Sciatica, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total lumbar disc prosthesis (Baguera®L, Spineart, Switzerland)Device
| Study group | Role | What they receive |
|---|---|---|
| Total Lumbar Disc replacement | These patients have been submitted to total lumbar disc replacement and we want to know the work and sportive activities they are able to undertake in the years after the total lumbar disc replacement Receives: Device: Total lumbar disc prosthesis (Baguera®L, Spineart, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to the original work after total lumbar disc replacement
Percentage of participants who returned to their original job after surgery.
Measured: Minimum of 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jan 2008
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Vanaclocha, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989632
- Sponsor's protocol ID
- 19/2024
- Status last verified
- May 2024
- First submitted
- 9 Jan 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skold C, Tropp H, Berg S. Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial. Eur Spine J. 2013 Oct;22(10):2288-95. doi: 10.1007/s00586-013-2926-y. Epub 2013 Jul 29.
PubMed 23893083Wei J, Song Y, Sun L, Lv C. Comparison of artificial total disc replacement versus fusion for lumbar degenerative disc disease: a meta-analysis of randomized controlled trials. Int Orthop. 2013 Jul;37(7):1315-25. doi: 10.1007/s00264-013-1883-8. Epub 2013 May 4.
PubMed 23645003Berg S, Tullberg T, Branth B, Olerud C, Tropp H. Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up. Eur Spine J. 2009 Oct;18(10):1512-9. doi: 10.1007/s00586-009-1047-0. Epub 2009 Jun 9.
PubMed 19506919Eliasberg CD, Kelly MP, Ajiboye RM, SooHoo NF. Complications and Rates of Subsequent Lumbar Surgery Following Lumbar Total Disc Arthroplasty and Lumbar Fusion. Spine (Phila Pa 1976). 2016 Jan;41(2):173-81. doi: 10.1097/BRS.0000000000001180.
PubMed 26751061Radcliff K, Spivak J, Darden B 2nd, Janssen M, Bernard T, Zigler J. Five-Year Reoperation Rates of 2-Level Lumbar Total Disk Replacement Versus Fusion: Results of a Prospective, Randomized Clinical Trial. Clin Spine Surg. 2018 Feb;31(1):37-42. doi: 10.1097/BSD.0000000000000476.
PubMed 28005616Song J, Katz A, Ngan A, Silber JS, Essig D, Qureshi SA, Virk S. Comparison of value per operative time between anterior lumbar interbody fusion and lumbar disc arthroplasty: A propensity score-matched analysis. J Craniovertebr Junction Spine. 2022 Oct-Dec;13(4):427-431. doi: 10.4103/jcvjs.jcvjs_99_22. Epub 2022 Dec 7.
PubMed 36777911Zigler J, Gornet MF, Ferko N, Cameron C, Schranck FW, Patel L. Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials. Global Spine J. 2018 Jun;8(4):413-423. doi: 10.1177/2192568217737317. Epub 2017 Nov 16.
PubMed 29977727Ding F, Jia Z, Zhao Z, Xie L, Gao X, Ma D, Liu M. Total disc replacement versus fusion for lumbar degenerative disc disease: a systematic review of overlapping meta-analyses. Eur Spine J. 2017 Mar;26(3):806-815. doi: 10.1007/s00586-016-4714-y. Epub 2016 Jul 23.
PubMed 27448810Mattei TA, Beer J, Teles AR, Rehman AA, Aldag J, Dinh D. Clinical Outcomes of Total Disc Replacement Versus Anterior Lumbar Interbody Fusion for Surgical Treatment of Lumbar Degenerative Disc Disease. Global Spine J. 2017 Aug;7(5):452-459. doi: 10.1177/2192568217712714. Epub 2017 Jul 7.
PubMed 28811990Geisler FH. Surgical treatment for discogenic low-back pain: lumbar arthroplasty results in superior pain reduction and disability level improvement compared with lumbar fusion. SAS J. 2007 Feb 1;1(1):12-9. doi: 10.1016/SASJ-2006-0002-RR. eCollection 2007.
PubMed 25802574Mu X, Wei J, A J, Li Z, Ou Y. The short-term efficacy and safety of artificial total disc replacement for selected patients with lumbar degenerative disc disease compared with anterior lumbar interbody fusion: A systematic review and meta-analysis. PLoS One. 2018 Dec 28;13(12):e0209660. doi: 10.1371/journal.pone.0209660. eCollection 2018.
PubMed 30592739Bai DY, Liang L, Zhang BB, Zhu T, Zhang HJ, Yuan ZG, Chen YF. Total disc replacement versus fusion for lumbar degenerative diseases - a meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Jul;98(29):e16460. doi: 10.1097/MD.0000000000016460.
PubMed 31335704Cui XD, Li HT, Zhang W, Zhang LL, Luo ZP, Yang HL. Mid- to long-term results of total disc replacement for lumbar degenerative disc disease: a systematic review. J Orthop Surg Res. 2018 Dec 26;13(1):326. doi: 10.1186/s13018-018-1032-6.
PubMed 30585142Gornet MF, Burkus JK, Dryer RF, Peloza JH, Schranck FW, Copay AG. Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study. J Neurosurg Spine. 2019 May 17;31(3):347-356. doi: 10.3171/2019.2.SPINE181037. Print 2019 Sep 1.
PubMed 31100723Panjabi M, Malcolmson G, Teng E, Tominaga Y, Henderson G, Serhan H. Hybrid testing of lumbar CHARITE discs versus fusions. Spine (Phila Pa 1976). 2007 Apr 20;32(9):959-66; discussion 967. doi: 10.1097/01.brs.0000260792.13893.88.
PubMed 17450069
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Lumbar Disc Prosthesis and Subsequent Work Activity 5 Years After Total Lumbar Disc Replacement
- ClinicalTrials.gov ID
- NCT06989632
- Acronym / sponsor ID
- 19/2024
- Conditions
- Lumbar Disc Degeneration, Lumbar Disc Disease, Sciatica, Lumbar Disc Herniation, Lumbar Degenerative Disease
- Keywords
- Chronic low back pain, Total lumbar disc replacement, Total lumbar disc arthroplasty, Sciatica
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lumbosciatica is a very prevalent pathology. When conservative treatments fail, surgery should be considered. The traditional surgical treatment is lumbar arthrodesis. The vast majority of patients who undergo spinal fusion cannot return to their same job and a good number of them never work again. Another form of treatment for lumbosciatica is the implantation of a lumbar disc prosthesis. This technique preserves the mobility of the lumbar area that has been operated on. This allows for a greater return to work and a higher percentage of those who return to the same job. This study aims to quantify how many of the patients who have had a lumbar disc prosthesis implanted in the last twenty years have returned to their same job, how many have had to change their jobs, and how many have not returned to work and are now totally or completely disabled from work.
Detailed description
Low back pain is one of the most prevalent pathologies in the world population and one of the most frequent causes of temporary and permanent work incapacity, particularly in today's largely sedentary society.
Although its etiology is broad, degenerative disc disease, herniated disc, and osteoarthritis of the facet joints are its most common causes.
Conservative treatments resolve many cases, but when they are not effective, surgical options must be considered. These can be classified into two groups: those involving vertebral fusion with loss of mobility at the level or levels in question and those attempting to preserve it.
In lumbar disc herniation, the classic treatment, discectomy, consists of more or less completely removing the nucleus pulposus through a relatively small posterior annulotomy. This causes a loss of height of the intervertebral disc and the foramina and overload of the articular facets, which over time can be accompanied by arthritic changes and trigger chronic lumbar pain.
In the degeneration of the intervertebral disc and the osteoarthritis of the articular facets, the traditional surgical technique is the arthrodesis of the vertebral segment or segments causing the symptoms. The immobilization of the painful spinal area limits the progression of the foraminal stenosis and the overload of the articular facets of the level or levels operated on. However, the fusion alters the biomechanics of the spine, causing the overload of the adjacent vertebral segments with degeneration and osteoarthritis of these, which is the cause of chronic pain. It is not uncommon that, over the years, reintervention is required to extend the arthrodesis. In turn, a larger area of fused spine will cause more overload of the adjacent levels, which will also suffer the same process of degeneration and arthrosis mentioned above, thus creating a vicious circle.
The initial step of fusion of the painful joint has also been followed in the spine in the attempt to preserve mobility by implanting a complete prosthesis of the intervertebral disc, provided that there is no degeneration or arthrosis of the articular facets. It is an option to consider compared to arthrodesis of the same segment with the appropriate surgical technique (posterolateral arthrodesis, PLIF, TLIF, X-LIF, ALIF, OLIF, 360º lumbar arthrodesis, etc.).
Studies comparing lumbar arthrodesis and arthroplasty indicate that complete lumbar disc prostheses provide a better quality of life, better control of lumbar and radicular pain symptoms, an earlier return to work, a lower incidence of adjacent level syndromes, and a lower number of complications and reinterventions. These differences are most noticeable during the first year after surgery, disappear after two years, and reappear after five years, due to the appearance of adjacent level syndrome. However, we have been able to find in the scientific literature after a thorough search which of the two surgical techniques, arthrodesis or arthroplasty at the lumbar level, achieves a greater return to the same job, or even if there are differences in terms of the work activity that each of the two surgical techniques allows. The objective of the present study is to first analyze in patients with complete lumbar disc prosthesis the percentage of return to the same job, of work activity even if it is in another job, if there is a change of work activity to what type it is changed and finally the percentage of patients who are left with work disability, of what kind and with what degree of disability. To compare with lumbar arthrodesis is not possible at this time because the arthrodesis technique, unlike arthroplasty, is very variable according to the surgeons on the team, and in our Institution, it is not possible to obtain retrospectively a homogeneous group with which to compare.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Lumbar Disc replacement | – | Device: Total lumbar disc prosthesis (Baguera®L, Spineart, Switzerland)These patients have been submitted to total lumbar disc replacement and we want to know the work and sportive activities they are able to undertake in the years after the total lumbar disc replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic lumbar degenerative disc herniation and/or lumbar disc herniation that underwent a total lumbar disc replacement
Key inclusion criteria (1 listed)
- Age over 18 years with symptomatic lumbar degenerative disc herniation and/or lumbar disc herniation.
Key exclusion criteria (1 listed)
- Any patient who BEFORE the implantation of a complete lumbar disc prosthesis had undergone any other type of surgical intervention on the lumbar spine. In particular, patients who had previously undergone a discectomy, whatever its form, or a spinal arthrodesis, whatever its technique, will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total lumbar disc prosthesis (Baguera®L, Spineart, Switzerland) | Device | Total Lumbar Disc replacement |
Primary outcome
Return to the original work after total lumbar disc replacement
Time frame: Minimum of 5 years after surgery
Percentage of participants who returned to their original job after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 23893083Skold C, Tropp H, Berg S. Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial. Eur Spine J. 2013 Oct;22(10):2288-95. doi: 10.1007/s00586-013-2926-y. Epub 2013 Jul 29.
- Background: PubMed 23645003Wei J, Song Y, Sun L, Lv C. Comparison of artificial total disc replacement versus fusion for lumbar degenerative disc disease: a meta-analysis of randomized controlled trials. Int Orthop. 2013 Jul;37(7):1315-25. doi: 10.1007/s00264-013-1883-8. Epub 2013 May 4.
- Background: PubMed 19506919Berg S, Tullberg T, Branth B, Olerud C, Tropp H. Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up. Eur Spine J. 2009 Oct;18(10):1512-9. doi: 10.1007/s00586-009-1047-0. Epub 2009 Jun 9.
- Background: PubMed 26751061Eliasberg CD, Kelly MP, Ajiboye RM, SooHoo NF. Complications and Rates of Subsequent Lumbar Surgery Following Lumbar Total Disc Arthroplasty and Lumbar Fusion. Spine (Phila Pa 1976). 2016 Jan;41(2):173-81. doi: 10.1097/BRS.0000000000001180.
- Background: PubMed 28005616Radcliff K, Spivak J, Darden B 2nd, Janssen M, Bernard T, Zigler J. Five-Year Reoperation Rates of 2-Level Lumbar Total Disk Replacement Versus Fusion: Results of a Prospective, Randomized Clinical Trial. Clin Spine Surg. 2018 Feb;31(1):37-42. doi: 10.1097/BSD.0000000000000476.
- Background: PubMed 36777911Song J, Katz A, Ngan A, Silber JS, Essig D, Qureshi SA, Virk S. Comparison of value per operative time between anterior lumbar interbody fusion and lumbar disc arthroplasty: A propensity score-matched analysis. J Craniovertebr Junction Spine. 2022 Oct-Dec;13(4):427-431. doi: 10.4103/jcvjs.jcvjs_99_22. Epub 2022 Dec 7.
- Background: PubMed 29977727Zigler J, Gornet MF, Ferko N, Cameron C, Schranck FW, Patel L. Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials. Global Spine J. 2018 Jun;8(4):413-423. doi: 10.1177/2192568217737317. Epub 2017 Nov 16.
- Background: PubMed 27448810Ding F, Jia Z, Zhao Z, Xie L, Gao X, Ma D, Liu M. Total disc replacement versus fusion for lumbar degenerative disc disease: a systematic review of overlapping meta-analyses. Eur Spine J. 2017 Mar;26(3):806-815. doi: 10.1007/s00586-016-4714-y. Epub 2016 Jul 23.
- Background: PubMed 28811990Mattei TA, Beer J, Teles AR, Rehman AA, Aldag J, Dinh D. Clinical Outcomes of Total Disc Replacement Versus Anterior Lumbar Interbody Fusion for Surgical Treatment of Lumbar Degenerative Disc Disease. Global Spine J. 2017 Aug;7(5):452-459. doi: 10.1177/2192568217712714. Epub 2017 Jul 7.
- Background: PubMed 25802574Geisler FH. Surgical treatment for discogenic low-back pain: lumbar arthroplasty results in superior pain reduction and disability level improvement compared with lumbar fusion. SAS J. 2007 Feb 1;1(1):12-9. doi: 10.1016/SASJ-2006-0002-RR. eCollection 2007.
- Background: PubMed 30592739Mu X, Wei J, A J, Li Z, Ou Y. The short-term efficacy and safety of artificial total disc replacement for selected patients with lumbar degenerative disc disease compared with anterior lumbar interbody fusion: A systematic review and meta-analysis. PLoS One. 2018 Dec 28;13(12):e0209660. doi: 10.1371/journal.pone.0209660. eCollection 2018.
- Background: PubMed 31335704Bai DY, Liang L, Zhang BB, Zhu T, Zhang HJ, Yuan ZG, Chen YF. Total disc replacement versus fusion for lumbar degenerative diseases - a meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Jul;98(29):e16460. doi: 10.1097/MD.0000000000016460.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Degeneration and Lumbar Disc Disease, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to the original work after total lumbar disc replacement (time frame: Minimum of 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06989632, which also lists 55 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.