Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies

NCT06448416 | Completed

• 1 other identifier: RGDS-2023-12-014
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods. With surgical techniques evolution, minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment. Several minimally invasive surgical endoscopic techniques have been developed for disc herniation: Single Portal Endoscopy (SE), Video Assisted Endoscopic Discectomy, and recently Unilateral Biportal Endoscopy (UBE). Currently, SE is considered as the minimally invasive surgery gold standard for HDL but, over the past two years, UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques. As an emerging technique, further studies are needed to better understand UBE. This is why Dr. Cristini's team wish to analyze a cohort of patients for whom this technique has been used since July 2022, in particular the complication rate. Controlling a new technique requires a learning phase. This is why Dr. Cristini's team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022.

Conditions

Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Patient complication rate

  Complications will include epidural hematoma, nerve root injury, neurological deficit, dural breach or tear, incomplete surgery, epileptic crisis, hypothermia. Other complications will be HDL recurrence, pain neuropathy, infection and thromboembolic complications

  2 days

Secondary Outcomes (1)

• surgeon learning curve

  21 months

Study Arms (1)

Unilateral Biportal Endoscopy (UBE) Technique

Patient with LDH treated by UBE

Procedure: UBE

Interventions

UBE PROCEDURE

Patients with HDL were treated with UBE

Unilateral Biportal Endoscopy (UBE) Technique

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

Study population means patients who fulfill inclusion and exclusion criteria

You may qualify if:

• Patient, male or female, over 18 years old
• Patient with lumbar disc herniation or non-instrumented degenerative lumbar pathology
• Patient operated with UBE technique

You may not qualify if:

• Patient with extreme lateral disc herniation.
• Patient suffering from other serious illnesses
• Patient with lumbar instability, lumbar infection or lumbar tumor,
• Patient with multi-segmental lumbar disease requiring treatment

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital CLAIRVAL

Marseille, 13009, France

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: July 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)