Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis

NCT04641039 | Recruiting DMC

• 1 other identifier: 101/2020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  One year

Study Arms (2)

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

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

Procedure: Anterior lumbar disc annulus removal versus replacement

Interventions

Anterior lumbar disc annulus removal versus replacement PROCEDURE

Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales

Anterior annulus removal; Anterior annulus replacement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 19927100 BACKGROUND

• Huang 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.

  PMID: 29322911 BACKGROUND

• Frelinghuysen 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.

  PMID: 15950689 RESULT

MeSH Terms

Conditions

Intervertebral disc disease

Central Study Contacts

Vicente Vanaclocha, MDPhD

CONTACT

+ 34 963 13 18 00; vivava@uv.es; vvanaclo@hotmail.com

Teresa Moratal, Secretary

CONTACT

+ 34 963 13 18 00; ceicvalencia_hgv@gva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be informed if the anterior annulus is removed or replaced
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor of Neurosurgery

Model Details: 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

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 23, 2020
• Study Start: November 1, 2020
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): December 28, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)