Clinical Trials Directory

Trials / Unknown

UnknownNCT04115202

Comparative Study of the Results of Anterior and Posterior Arthrodesis in Degenerative Lumbar Pathology

Status
Unknown
Phase
Study type
Observational
Enrollment
254 (estimated)
Sponsor
Ramsay Générale de Santé · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To compare the functional results through the improvement of the Oswestry medium-term score of the lumbar arthrodesis performed to treat patients with lumbago and/or lumbar-radicular pain due to degenerative lesions of the lumbar spine: degenerative disc disease, osteoarthritis spondylolisthesis or adult dislocation scoliosis.

Detailed description

Lower back pain is the leading cause of disability in France for adults under 45 years of age. It is also the leading cause of work stoppage and reported occupational illnesses. Thus, the degenerative pathologies of the lumbar spine can be at the origin of a severe handicap resistant to well-conducted medical treatment. This is particularly the case for degenerative disc disease, osteoarthritic spondylolisthesis and scoliotic dislocations in adults. If lumbar arthrodesis is a recognised solution in the surgical treatment of degenerative diseases of the lumbar spine when they become disabling despite medical treatment, the choice of the operative technique and approach used to achieve it is more dependent of the training that the practitioner benefited from than the guidelines derived from published prospective comparative scientific studies comparing the results of different surgical solutions. Our hypothesis is that the functional and radiographic results of anterior lumbar arthrodesis techniques by minimally invasive approach may differ from those of conventional posterolateral arthrodesis. We propose to compare the results of these two surgical techniques within the orthopedic and neurosurgeon team of the Institut Parisien du Dos, mastering these two approaches optimally by leaving them free to use them as they do daily without modifying their procedures. This should allow us to judge, in a well-defined population, whether one of the two techniques is superior to the other when performed by surgeons who are experienced in this surgery.

Conditions

Interventions

TypeNameDescription
PROCEDURElumbar arthrodesistwo approaches anterior versus posterior, optimally by leaving physicians free to use them as they do daily without modifying their procedures

Timeline

Start date
2018-05-31
Primary completion
2020-07-31
Completion
2020-07-31
First posted
2019-10-03
Last updated
2019-10-03

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04115202. Inclusion in this directory is not an endorsement.