Status:
COMPLETED
Efficacy and Safety of IntraSPINE® Associated with Discectomy in the Treatment of Lumbar Disc Herniation.
Lead Sponsor:
Quanta Medical
Collaborating Sponsors:
Cousin Biotech
Conditions:
Disk Herniated Lumbar
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motio...
Eligibility Criteria
Inclusion
- Disease-related criteria:
- single segment L4-L5 or L5-S1 lumbar disc hernia identified on imaging (lumbar spine MRI)
- median or posterolateral disc hernia.
- failure of correct medical treatment which has not provided lasting symptom relief absence of contraindications to surgical discectomy and implantation of the IntraSPINE®.
- Population related criteria:
- subjects of either sex and over 18 years old
- who have given their free informed signed consent to participate in the study
- patients who are able to respond to the questionnaires and who can communicate in the language of the study country
- and who are affiliated to a social security system or have rights from a social security system.
Exclusion
- Disease-related criteria:
- recurrent disc hernia post-discectomy at any level
- foraminal and extra-foraminal disc hernia
- paralysing disc hernia (score of 3/5 or less) and cauda equina syndrome
- any grade of spondylolisthesis
- degenerative scoliosis ≥ 15°
- osteoporosis or Paget's disease
- BMI \> 30
- procedure required on more than one vertebral level
- endoscopic microdiscectomy prohibiting insertion of the IntraSPINE®
- chronic infection
- systemic or metabolic disorders
- active ongoing malignant disease (liable to prevent the study being conducted and does not carry a risk of vertebral lysis)
- occupational disorder responsible for the disease Treatment or device-related criteria
- allergy to any of the constituents of the medical device
- Population-related criteria:
- past history of spinal procedure.
- withdrawal of consent
- pregnant women
- breast-feeding women
- participation in a clinical study within 3 months before the initial visit.
- drug addiction
- predictable lack of availability during the study. Patients deprived of their freedom or under legal guardianship.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT03752671
Start Date
May 20 2019
End Date
February 28 2024
Last Update
March 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
George Pompidou European Hospital
Paris, Paris, France, 75015