Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease

NCT07790328 | Recruiting

• 1 other identifier: RC-P-T3-39
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study designed as an extension of a prospective study conducted between 2012 and 2017. Patients who were originally enrolled in the initial study are being recontacted for follow-up assessment, including evaluation of clinical and radiological (MRI) criteria. Approximately 50 patients have been included to date and their long terms results (at least 9 years) will be assessed.

Conditions

Lower Back Pain of Disc Origin; Joint Facet Syndrome; Lumbar Canal Stenosis; Spinal Disease

Outcome Measures

Primary Outcomes (1)

• Clinical success rate at long term (at least 9 years)

  The clinical success is defined by : * An improvement (decrease) in the ODI score of at least 30% compared to the score at enrollment in the pivotal study * No complications such as revision, reoperation, implant removal, infection, or any other adverse events related to the surgery or the device since enrollment in the pivotal study

  At least 9 years after enrollment in the pivotal study

Secondary Outcomes (22)

• Degree of functional disability

  At least 9 years after enrollment in the pivotal study

• Radicular and low back pain

  At least 9 years after enrollment in the pivotal study

• Walking time

  At least 9 years after enrollment in the pivotal study

• Finger-to-floor test

  At least 9 years after enrollment in the pivotal study

• Disc height (anterior and posterior)

  At least 9 years after enrollment in the pivotal study

Study Arms (1)

IntraSPINE

The IntraSPINE® implant is a widely used dynamic interlaminar stabilization device that differs from other inter-spinal devices (ISDs) in its structure and its more anterior positioning relative to the spinal axis. This device is a dimethyl siloxane (silicone) implant covered with a polyethylene terephthalate mesh. Its anterior surface, which comes into contact with the ligamentum flavum (when it is left in place) or with the dura mater, is coated with an anti-adhesive coating. The device is an elastic support with a cushioning effect. The stiffer anterior portion provides strong distraction, while the more flexible posterior tunnel acts as a stress absorber. The lateral wings secure the device in place, preventing any migration.

Drug: IntraSPINE

Interventions

IntraSPINE DRUG

Intraspine is an interlaminar device not interspinous.

Also known as: Interlaminar device

IntraSPINE

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

The study population included adult patients from the Princeps study (INTREUR) who completed the 36-month follow-up. Eligible patients had degenerative lumbar disc disease at one or two levels, underwent IntraSPINE® implantation following failure of conservative treatment, and had no device removal during follow-up or underwent replacement with a new IntraSPINE® device at the 36-month visit. All patients received study information and provided written informed non-opposition.

You may qualify if:

• Adult patient,
• Patient with degenerative lumbar disc disease at one or two levels for whom
• Surgery involving the placement of an IntraSPINE® implant has been indicated following the failure of conservative treatment,
• Patient who has read and signed the information and consent form

You may not qualify if:

• Patients with the following contraindications:
• Allergy to any of the components,
• Infected site,
• Pregnant women.
• Patients with spondylolisthesis with isthmic lysis

Sponsors & Collaborators

• Cousin Biotech: lead

Study Sites (1)

Maison des consultations

Saran, France

RECRUITING

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 27, 2026
• Study Start: July 28, 2020
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2031
• Last Updated: August 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)