To evaluate the safety (local and systemic) of a specific surgical intervention with the use of NVD-001 (AEs, AESI, SAEs) in patients with symptomatic low-grade degenerative spondylolisthesis grade I or II undergoing surgery for spinal fusion of one vertebral segment (L1-S1)

Phase 1

• Conditions: Patients diagnosed with symptomatic degenerative spondylolisthesis grade I or II with an indication for spinal fusion of one vertebral segment (L1-S1).; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002642-23-BE
• Lead Sponsor: ovadip Biosciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-26
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Subject has understood and accepted to participate in the study according to all study procedures by signing the approved informed consent.
• Male or female subjects aged =18 and is skeletally mature (epiphyses closed) at Visit V0a.
• Subject has clinically important pain or neurological symptoms at V0a with or without claudication due to symptomatic degenerative spondylolisthesis grade I or II. (Meyerding Classification)
• Conservative treatment of disease has failed for at least 3 months since diagnosis. (ISASS 2011)
• Subject has a preoperative ODI score >30.
• Subject has an indication for spinal fusion of one vertebral segment (L1-S1) due to symptomatic degenerative spondylolisthesis grade I or II diagnosed by computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and/or dynamic radiography.
• Subject is suitable for surgical operation and incorporation of the PEEK cage(s) by transforaminal lumbar interbody fusion (TLIF) or posterior lumbar intervertebral fusion (PLIF) by minimally invasive or open approach in one mobile segment (L1- S1) with bilateral rigid fixation. No posterolateral lumbar fusion (PLF) technique is allowed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

• Subject has known history of hypersensitivity or anaphylactic reaction to PEEK.
• Due to medical or other reasons spine fusion cannot be delayed for up to 6 months.
• Indications for spinal fusion other than symptomatic degenerative spondylolisthesis grade I and II (Meyerding Classification).
• Subject has documented metabolic disease such as but not limited to severe osteoporosis, osteogenesis imperfect, or osteomalacia.
• Subject with poorly controlled diabetes mellitus as assessed by glycohaemoglobin (HbA1c) > 8% (at least 2 values per year for last 2 years)
• Subject is underweight, i.e. body mass index (BMI) =18.5 or has a BMI of =40, or =35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes at V0a.
• Overt or active local or systemic infection, including latent infection around (area of) the future surgical implant site.
• Subject has a history of previously attempted spinal fusion at the same level, or spine level immediately adjacent to the level to be operated on in this study. Decompressive surgery alone (laminectomy) is not an exclusion criterion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified