Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF

February 19, 2024 updated by: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.

A Prospective, Single Center, Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in Transforaminal Lumbar Interbody Fusion

The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.

The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:

  • To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.
  • To evaluate if implantation causes significant increase quality of life of the patients.
  • To evaluate if using the device can be considered as safe overall.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Degenerative disc and facet joint disease of the lumbar spine is common in the ageing population and is one of the most frequent causes of disability. Lumbar spondylosis may result in mechanical back pain, radicular and claudicant symptoms, reduced mobility and poor quality of life. Surgical interbody fusion of degenerative levels is an effective treatment option to stabilize the painful motion segment, and may provide indirect decompression of the neural elements, restore lordosis and correct deformity. Lumbar interbody fusion (LIF) involves placement of an implant (cage, spacer or structural graft) within the intervertebral space after discectomy and endplate preparation. At this time LIF is performed using five main approaches; posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), oblique lumbar interbody fusion/anterior to psoas (OLIF/ATP), anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). There is no clear definitive evidence for one approach being superior to another in terms of fusion or clinical outcomes. These operations can also be performed using mini-open or minimally invasive (MIS) approaches, however it has not yet been demonstrated that MIS-TLIF is clinically superior to traditional open TLIF procedure. Interbody fusion is preferable to postero-lateral 'onlay' fusion techniques due to lower rates of postoperative complications and pseudoarthrosis.

Posterior interbody fusion (PLIF), combined with segmental instrumentation, has become increasingly popular since it was first described by Mercer in 1936 and expanded upon by Cloward. More recently however, the transforaminal approach to the intervertebral disc, known as transforaminal lumbar interbody fusion (TLIF), has gained popularity. Originally described by Harms in the late 1990s, the TLIF has arguably developed into the most commonly performed and efficacious posterior interbody fusion method in modern spine surgery.

Transforaminal lumbar interbody fusion (TLIF) utilizes a more lateral window in order to access the interbody space without excessive dural retraction. Theoretical advantages of TLIF include increased fusion success, more complete foraminal decompression, better correction of deformity, and more effective treatment of discogenic pain.

Transforaminal lumbar interbody fusion (TLIF) have demonstrated excellent fusion rates with acceptable complication profiles for treating single and multilevel lumbar disc pathology and instability. TLIF have been shown to be superior to posterolateral fusion alone for deformity correction and more cost effective than anterior interbody combined with posterior segmental instrumentation.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
    • Pest
      • Budapest, Pest, Hungary, 1126
        • Recruiting
        • National Center for Spinal Disorders
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Each subject must meet all the following criteria to be enrolled in this study:

All subjects who had previously indicated for TLIF surgery can participate in this study, with the following evidence:

  1. Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L1 to S1), manifested by:

    1. Low back pain, or
    2. Irradiating leg or buttock pain, paresthesia, numbness, or weakness, or
    3. History of neurogenic claudication.

  2. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:

    1. Instability as defined by ≥3 mm translation or ≥5-degree angulation
    2. Decreased disc height, on average by ≥2 mm, but dependent upon the spinal level
    3. Scarring/thickening of ligamentum flavum or annulus fibrosis
    4. Herniated nucleus pulposus
    5. Vacuum phenomenon
    6. Grade 1 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, Henry William, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or
    7. Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
    8. Recurrent disc herniation

Further inclusion criteria:

  • Skeletally mature adults ages 18 - 80 years of age
  • Able to read and understand all documents used in this study, including the informed consent and patient-reported outcome questionnaires

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

  1. Prior surgical procedure at the involved or adjacent spinal levels (e.g. stabilization, fusion, arthroplasty and/or other non-fusion procedures). Prior microdiscectomy, discectomy, laminectomy, decompression surgery at the target or adjacent levels is allowed.
  2. Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
  3. Planned use of an internal or external bone growth stimulator.
  4. Lumbar scoliosis >30 degrees.
  5. Patients who had a previous diagnosis of osteoporosis with a Tscore of -2.5 or below in the last 12 months. If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA (dual x-ray absorptiometry) scan will need to be obtained.
  6. Morbidly obese, as defined by a Body Mass Index (BMI) >40.
  7. Presence of active malignancy or prior history of malignancy (noninvasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
  8. Overt or active bacterial infection, either local to surgical space or systemic.

  9. Has undergone administration of any type of corticosteroid, antineoplastic, immunostimulant, or immunosuppressive agents, or medications known to inhibit with the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment

    1. This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment
    2. Use of steroidal inhalers, short-term NSAID use, and shortterm steroidal use (e.g. Medrol Dosepak) is allowed pre and postoperatively. For this clinical study, short-term use is defined as ≤ two weeks.
    3. Use of NSAIDs and/or steroids for longer than two weeks postoperatively through the 24 Month Follow-Up Visit is not recommended. Such patients must be excluded from data analysis in case of non-fusion.
  10. Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
  11. Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
  12. Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
  13. Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g.: monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK).
  14. History of any allergy resulting in anaphylaxis.
  15. Is mentally incompetent. If questionable, obtain psychiatric consult.
  16. Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
  17. Pregnancy and breastfeeding.
  18. A documented diagnosis of substance use disorder (Nicotine use is allowed.)
  19. Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.
  20. Subject is considered to belong to a vulnerable population.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Prospective, single-arm, open-label clinical trial.
Single center, prospective cohort, single-arm, open-label clinical trial Standard-of-care & Sanatmetal ReSpace TiCell Cage implantation A single-center study is sufficient to provide confirmatory data on performance and safety of the investigational device.
Device: ReSpace TiCell Cage

ReSpace TiCell Cages are anatomically shaped interbody spacer implants with curved contour. These implants intended to be inserted into the intervertebral disc space for intervertebral body fusion. The interbody spacers are designed to restore height and lordotic angle in the spine. The spacers have teeth on the endplate-engaging surfaces to provide stability, resist shear and rotational forces, and to help prevent migration of the spacer within the disc space. The open central cavity on them allows for placement of graft material allowing for subsequent bone growth through the interior of the devices.

ReSpace TiCell Cages are indicated for lumbar spine stabilization (between L.I.-S.I. segments). TLIF spine surgery will be combined with posterior fixation using pedicle screws and rods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT imaging_1 - cumulative fusion rate
Time Frame: At visit 4 (Month 24)
For the determination of the cumulative fusion rate, radiographic evaluation (CT imaging with fine-cut axial and multiplanar reconstruction views) will be conducted by 2 independent examiners.
At visit 4 (Month 24)
CT imaging_2 - fusion status
Time Frame: At visit 4 (Month 24)
Standing flexion-extension angle will be measured with dynamic plain radiography to evaluate mobility to determine the fusion status.
At visit 4 (Month 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: At visits 1/2/3/4 (Months 3/6/12 and 24)
The severity of back, hip/buttock, and leg pain will each be evaluated in all study subjects using a 100-mm Visual Analog Scale (VAS). Minimum value is 0mm, maximum value is 100mm. The low value means low intensity of the pain, which is the aim of the treatment.
At visits 1/2/3/4 (Months 3/6/12 and 24)
Oswestry Disability Index (ODI)
Time Frame: At visits 1/2/3/4 (Months 3/6/12 and 24)
Oswestry Disability Index (ODI) is a validated, independent outcome measure. It is one of the principal condition-specific outcome measures used in the management of spinal disorders and in patients with low back pain. The questionnaire contains 10 questions. There are 6 possible answers available to each questions. The 1. answer means each time the lowest pain, which is the aim of the treatment. At the end the doctor calculate a rate of the patient pain in %.
At visits 1/2/3/4 (Months 3/6/12 and 24)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE and ADE
Time Frame: During the study (32 months)
To prove the safe and effective use of the medical device. Number of patients with Adverse Events (AE) and Adverse Device Effects (ADE) are administered and observed during the study.
During the study (32 months)
Complications
Time Frame: During the study (32 months)
To prove the safe and effective use of the medical device. The rate of complications is administered and observed during the study.
During the study (32 months)
Surgical revisions
Time Frame: During the study (32 months)
To prove the safe and effective use of the medical device. The rate of surgical revisions is administered and observed during the study.
During the study (32 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.

Investigators

  • Principal Investigator: Aron Lazary, MD, PhD, National Center for Spinal Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SANAT-CAGE-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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