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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital General Universitario de Valencia
RECRUITING
Valencia
Contact Information
Primary
Vicente Vanaclocha, MDPhD
vivava@uv.es; vvanaclo@hotmail.com
+ 34 963 13 18 00
Backup
Teresa Moratal, Secretary
ceicvalencia_hgv@gva.es
+ 34 963 13 18 00
Time Frame
Start Date: 2020-11-01
Estimated Completion Date: 2026-12-28
Participants
Target number of participants: 24
Treatments
Active_comparator: Anterior annulus removal
In these patients the anterior portion of the annulus fibrosus will be removed when inserting a complete lumbar disc prosthesis
Active_comparator: Anterior annulus replacement
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
Sponsors
Leads: University of Valencia

This content was sourced from clinicaltrials.gov