Lumbar Disc DiseaseNCT04641039
Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis
A study testing Anterior lumbar disc annulus removal versus replacement in people with Lumbar Disc Disease, run by University of Valencia at 1 site in Spain.
Trial summary
To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. As the anterior portion of the annulus limits the movement in extension and axial rotation, we would like to know how much increase these two disc movements and also the effect on the postoperative… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- Anterior lumbar disc annulus removal versus replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 28 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Minimum age of 18 years and maximum of 50 years, given that above that age there is usually degenerative pathology of the lumbar joint facets, which can confuse the symptoms and make it difficult to interpret the results.
- Pathology compatible with chronic low back pain accompanied or not by radiculopathy originating in one or a maximum of two degenerated intervertebral discs and without signs of degeneration / osteoarthritis of the lumbar joint facets.
- The type of lumbar pain must be discogenic, that is, worsen in flexion and not in extension, and in loading, as well as having a truncal distribution with possible anterior radiation towards the English or genital region.
- Radiological confirmation by lumbar MRI study of lumbar discopathy of one or a maximum of two lumbar levels.
- Absence in simple radiology studies of signs of vertebral instability or listhesis of the levels to be treated.
- Absence of response for 6 weeks to conservative, non-surgical treatment, or presence of progressive symptoms. The treatment would also be carried out despite the absence of this study and the existence of the study does not condition in any way the treatment of the patients
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- Not having undergone any prior treatment of the type of microdiscectomy, laminectomy or lumbar arthrodesis, although these have been carried out at different levels than those involved on this occasion
- Ability of the patient to comply with the proposed monitoring program
- Patient's ability to follow the postoperative care program
- Granting of informed consent
Who cannot join
- Signs of arthropathy of the lumbar joint facets, osteoporosis, previous interventions on the lumbar spine
- Deformity or instability of the lumbar spine
- Lumbar canal stenosis
- Previous intervention on lumbar spine
- Previous lumbar spinal fracture
- Mobile spondylolisthesis> 2 mm in translation and / or more than 11 ° angular difference with respect to the adjacent level on neutral vertical or flexion-extension radiographs
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- Severe osteoporosis
- Spinal metastasis
- Metabolic bone disease that could interfere with the implant or the surgical procedure
- Rheumatoid arthritis, lupus, or other autoimmune disease that affects the musculoskeletal system
- Other conditions or anatomical alterations that make the treatment of the anterior approach to the lumbar spine unfeasible
- Known allergy to stainless steel, titanium or their alloys
- Fixed or permanent neurological deficit
- Active systemic infection at any time or ongoing preventive treatment for it, infection in the surgical site, HIV or hepatitis C
- Abusive drug or alcohol use
- Uncontrolled seizure disorder
- Psychiatric illness that could interfere with your participation in the study
- Participation in a current research study or in the 3 months prior to surgery
- History of malignancy or current malignancy (except non-melanoma skin cancer), unless the patient has been treated for curative purposes and no clinical signs or symptoms have been observed for at least 5 years
- Obesity (Body Mass Index or BMI> 35)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Vicente Vanaclocha, MDPhD, +34 963 13 18 00 ext. 438500, vivava@uv.es; vvanaclo@hotmail.com
Teresa Moratal, +34 963 13 18 00 ext. 437334, ceicvalencia_hgv@gva.es
About this study
Official title: Effect of the Postoperative Prevertebral Scar on Controlling Excess After Removing the Anterior Lumbar Disc Annulus Fibrosus to Implant a Lumbar Disc Prosthesis. Biomechanical and Clinical Study
To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. As the anterior portion of the annulus limits the movement in extension and axial rotation, we would like to know how much increase these two disc movements and also the effect on the postoperative prevertebral scar on the reduction of these abnormal movement ranges. We also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved.
Read the detailed description
To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. It is known that the anterior portion of the annulus limits the movement in extension and axial rotation, so removal of this section of the annulus fibrosus will increase the range of movement in extension and axial rotation. As far as the investigators know, this increase in movement ranges has not been measured objectively in alive patients. Also the investigators would like to know if the postoperative prevertebral scar reduces an to what extent these abnormal movement ranges. This could help the investigators to decide when patients should be allowed to regain normal activities and specially, when the patients should be allowed to start working again. The investigators also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved, and thus represents an improvement or not in the care of these patients
- Conditions
- Lumbar Disc Disease
- Being tested
- Anterior lumbar disc annulus removal versus replacement
- Keywords
- Annulus fibrosus, Lumbar disc prosthesis, Lumbar disc replacement, Range of movement lumbar disc prosthesis, Quality of life after lumbar disc replacement
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior lumbar disc annulus removal versus replacementProcedure or surgery
Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales
| Study group | Role | What they receive |
|---|---|---|
| Anterior annulus removal | Active comparator | In these patients the anterior portion of the annulus fibrosus will be removed when inserting a complete lumbar disc prosthesis Receives: Procedure: Anterior lumbar disc annulus removal versus replacement |
| Anterior annulus replacement | Active comparator | In these group of patients the anterior portion of the annulus fibrosus will be opened up in to flaps hinged lateraly and replaced once the complete lumbar disc prosthesis is inserted Receives: Procedure: Anterior lumbar disc annulus removal versus replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of spinal segment movement after lumbar disc prosthesis insertion in L4-L5 lumbar disc
The investigators will analyze preoperatively and postoperatively at 3, 6 and 12 months the range of movement of the L4-L5 lumbar disc after insertion of a complete lumbar disc prosthesis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Nov 2020
- Primary completion28 Dec 2029 (estimated)
- Study completion28 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups. In one the anterior annulus will be removed to insert a lumbar disc prosthesis and in the other this section of the anterior annulus will be opened up in two flaps hinged lateraly and replaced once the complete lumbar disc prosthesis is implanted
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 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
- NCT04641039
- Sponsor's protocol ID
- 101/2020
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Auerbach JD, Jones KJ, Milby AH, Anakwenze OA, Balderston RA. Segmental contribution toward total lumbar range of motion in disc replacement and fusions: a comparison of operative and adjacent levels. Spine (Phila Pa 1976). 2009 Nov 1;34(23):2510-7. doi: 10.1097/BRS.0b013e3181af2622.
PubMed 19927100Huang YJ, Zhao SJ, Zhang Q, Nong LM, Xu NW. Comparison of lumbar pedicular dynamic stabilisation systems versus fusion for the treatment of lumbar degenerative disc disease: A meta-analysis. Acta Orthop Belg. 2017 Mar;83(1):180-193.
PubMed 29322911Frelinghuysen P, Huang RC, Girardi FP, Cammisa FP Jr. Lumbar total disc replacement part I: rationale, biomechanics, and implant types. Orthop Clin North Am. 2005 Jul;36(3):293-9. doi: 10.1016/j.ocl.2005.02.014.
PubMed 15950689
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Postoperative Prevertebral Scar on Controlling Excess After Removing the Anterior Lumbar Disc Annulus Fibrosus to Implant a Lumbar Disc Prosthesis. Biomechanical and Clinical Study
- ClinicalTrials.gov ID
- NCT04641039
- Acronym / sponsor ID
- 101/2020
- Conditions
- Lumbar Disc Disease
- Keywords
- Annulus fibrosus, Lumbar disc prosthesis, Lumbar disc replacement, Range of movement lumbar disc prosthesis, Quality of life after lumbar disc replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Dec 2029 (estimated)
- Study completion
- 28 Dec 2029 (estimated)
- First posted
- 23 Nov 2020 (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.
To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. As the anterior portion of the annulus limits the movement in extension and axial rotation, we would like to know how much increase these two disc movements and also the effect on the postoperative prevertebral scar on the reduction of these abnormal movement ranges. We also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved.
Detailed description
To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. It is known that the anterior portion of the annulus limits the movement in extension and axial rotation, so removal of this section of the annulus fibrosus will increase the range of movement in extension and axial rotation. As far as the investigators know, this increase in movement ranges has not been measured objectively in alive patients. Also the investigators would like to know if the postoperative prevertebral scar reduces an to what extent these abnormal movement ranges. This could help the investigators to decide when patients should be allowed to regain normal activities and specially, when the patients should be allowed to start working again. The investigators also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved, and thus represents an improvement or not in the care of these patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups. In one the anterior annulus will be removed to insert a lumbar disc prosthesis and in the other this section of the anterior annulus will be opened up in two flaps hinged lateraly and replaced once the complete lumbar disc prosthesis is implanted
| Arm | Type | Receives |
|---|---|---|
| Anterior annulus removal | Active comparator | Procedure: Anterior lumbar disc annulus removal versus replacementIn these patients the anterior portion of the annulus fibrosus will be removed when inserting a complete lumbar disc prosthesis |
| Anterior annulus replacement | Active comparator | Procedure: Anterior lumbar disc annulus removal versus replacementIn these group of patients the anterior portion of the annulus fibrosus will be opened up in to flaps hinged lateraly and replaced once the complete lumbar disc prosthesis is inserted |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Minimum age of 18 years and maximum of 50 years, given that above that age there is usually degenerative pathology of the lumbar joint facets, which can confuse the symptoms and make it difficult to interpret the results.
- Pathology compatible with chronic low back pain accompanied or not by radiculopathy originating in one or a maximum of two degenerated intervertebral discs and without signs of degeneration / osteoarthritis of the lumbar joint facets.
- The type of lumbar pain must be discogenic, that is, worsen in flexion and not in extension, and in loading, as well as having a truncal distribution with possible anterior radiation towards the English or genital region.
- Radiological confirmation by lumbar MRI study of lumbar discopathy of one or a maximum of two lumbar levels.
- Absence in simple radiology studies of signs of vertebral instability or listhesis of the levels to be treated.
Key exclusion criteria (20 listed)
- Signs of arthropathy of the lumbar joint facets, osteoporosis, previous interventions on the lumbar spine
- Deformity or instability of the lumbar spine
- Lumbar canal stenosis
- Previous intervention on lumbar spine
- Previous lumbar spinal fracture
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 |
|---|---|---|
| Anterior lumbar disc annulus removal versus replacementOwestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales | Procedure or surgery | Anterior annulus removal, Anterior annulus replacement |
Primary outcome
Range of spinal segment movement after lumbar disc prosthesis insertion in L4-L5 lumbar disc
Time frame: One year
The investigators will analyze preoperatively and postoperatively at 3, 6 and 12 months the range of movement of the L4-L5 lumbar disc after insertion of a complete lumbar disc prosthesis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 19927100Auerbach JD, Jones KJ, Milby AH, Anakwenze OA, Balderston RA. Segmental contribution toward total lumbar range of motion in disc replacement and fusions: a comparison of operative and adjacent levels. Spine (Phila Pa 1976). 2009 Nov 1;34(23):2510-7. doi: 10.1097/BRS.0b013e3181af2622.
- Background: PubMed 29322911Huang YJ, Zhao SJ, Zhang Q, Nong LM, Xu NW. Comparison of lumbar pedicular dynamic stabilisation systems versus fusion for the treatment of lumbar degenerative disc disease: A meta-analysis. Acta Orthop Belg. 2017 Mar;83(1):180-193.
- Results publication: PubMed 15950689Frelinghuysen P, Huang RC, Girardi FP, Cammisa FP Jr. Lumbar total disc replacement part I: rationale, biomechanics, and implant types. Orthop Clin North Am. 2005 Jul;36(3):293-9. doi: 10.1016/j.ocl.2005.02.014.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior lumbar disc annulus removal versus replacement in people with 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 10 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 22 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicente Vanaclocha, MDPhD (+ 34 963 13 18 00 ext. 438500, vivava@uv.es; vvanaclo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of spinal segment movement after lumbar disc prosthesis insertion in L4-L5 lumbar disc (time frame: One year). 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 NCT04641039, which also lists 3 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 22 Apr 2026.