Total Lumbar Disc Prosthesis and Subsequent Work Activity at at Least Five Years After Total Lumbar Disc Replacement

NCT06989632 | Recruiting DMC

• 1 other identifier: 19/2024
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• Number of participants who have had a lumbar disc prosthesis implanted in the last twenty years and have returned to their same job

  Percentage of participants who have not returned to work and are now totally or completely disabled from work

  We started to implant total lumbar disc prosthesis in 2006 and have continued up to now. We want to know the results in our patients re work and sport activities at 01 May 2025

Study Arms (1)

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

Device: We want to know the work and sport activities that our patients are able to undertake after a total lumbar disc replacement

Interventions

We want to know the work and sport activities that our patients are able to undertake after a total lumbar disc replacement DEVICE

Total Lumbar Disc replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic lumbar degenerative disc herniation and/or lumbar disc herniation that underwent a total lumbar disc replacement

You may qualify if:

• Age over 18 years with symptomatic lumbar degenerative disc herniation and/or lumbar disc herniation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, 46015, Spain

RECRUITING

Related Publications (55)

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MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral disc disease; Sciatica; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia; Pathological Conditions, Anatomical

Central Study Contacts

Vicente Vanaclocha, Professor

CONTACT

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

Teresa Moratal, Secretary

CONTACT

moratal_gva@uv.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: May 25, 2025
• Study Start: January 1, 2006
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 25, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)