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

NCT06265038 | Recruiting DMC

• 1 other identifier: SANAT-CAGE-2022
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Instability; Spondylolisthesis; Post-discectomy Syndrome; Post-traumatic Instability

Keywords

lumbar spinal; interbody fusion; interbody cage; 3D printing

Outcome Measures

Primary Outcomes (2)

• CT imaging_1 - cumulative fusion rate

  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

  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 Outcomes (2)

• Visual Analog Scale

  At visits 1/2/3/4 (Months 3/6/12 and 24)

• Oswestry Disability Index (ODI)

  At visits 1/2/3/4 (Months 3/6/12 and 24)

Other Outcomes (3)

• AE and ADE

  During the study (32 months)

• Complications

  During the study (32 months)

• Surgical revisions

  During the study (32 months)

Study Arms (1)

Prospective, single-arm, open-label clinical trial.

OTHER

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

Interventions

ReSpace TiCell Cage DEVICE

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.

Prospective, single-arm, open-label clinical trial.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L1 to S1), manifested by:
• Low back pain, or
• Irradiating leg or buttock pain, paresthesia, numbness, or weakness, or
• History of neurogenic claudication.
• Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:
• Instability as defined by ≥3 mm translation or ≥5-degree angulation
• Decreased disc height, on average by ≥2 mm, but dependent upon the spinal level
• Scarring/thickening of ligamentum flavum or annulus fibrosis
• Herniated nucleus pulposus
• Vacuum phenomenon
• 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
• Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
• Recurrent disc herniation

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• 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.
• 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.
• Planned use of an internal or external bone growth stimulator.
• Lumbar scoliosis \>30 degrees.
• 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.
• Morbidly obese, as defined by a Body Mass Index (BMI) \>40.
• 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).
• Overt or active bacterial infection, either local to surgical space or systemic.
• 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
• 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
• 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.
• 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.
• Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
• 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).

Sponsors & Collaborators

• Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.: lead

Study Sites (1)

National Center for Spinal Disorders

Budapest, Pest County, 1126, Hungary

RECRUITING

Related Publications (14)

• Ajiboye RM, Alas H, Mosich GM, Sharma A, Pourtaheri S. Radiographic and Clinical Outcomes of Anterior and Transforaminal Lumbar Interbody Fusions: A Systematic Review and Meta-analysis of Comparative Studies. Clin Spine Surg. 2018 May;31(4):E230-E238. doi: 10.1097/BSD.0000000000000549.

  PMID: 28622187 RESULT

• Kim JS, Kang BU, Lee SH, Jung B, Choi YG, Jeon SH, Lee HY. Mini-transforaminal lumbar interbody fusion versus anterior lumbar interbody fusion augmented by percutaneous pedicle screw fixation: a comparison of surgical outcomes in adult low-grade isthmic spondylolisthesis. J Spinal Disord Tech. 2009 Apr;22(2):114-21. doi: 10.1097/BSD.0b013e318169bff5.

  PMID: 19342933 RESULT

• Kim JS, Lee KY, Lee SH, Lee HY. Which lumbar interbody fusion technique is better in terms of level for the treatment of unstable isthmic spondylolisthesis? J Neurosurg Spine. 2010 Feb;12(2):171-7. doi: 10.3171/2009.9.SPINE09272.

  PMID: 20121352 RESULT

• Crandall DG, Revella J. Transforaminal lumbar interbody fusion versus anterior lumbar interbody fusion as an adjunct to posterior instrumented correction of degenerative lumbar scoliosis: three year clinical and radiographic outcomes. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2126-33. doi: 10.1097/BRS.0b013e3181b612db.

  PMID: 19752698 RESULT

• Dorward IG, Lenke LG, Bridwell KH, O'Leary PT, Stoker GE, Pahys JM, Kang MM, Sides BA, Koester LA. Transforaminal versus anterior lumbar interbody fusion in long deformity constructs: a matched cohort analysis. Spine (Phila Pa 1976). 2013 May 20;38(12):E755-62. doi: 10.1097/BRS.0b013e31828d6ca3.

  PMID: 23442780 RESULT

• Faundez AA, Schwender JD, Safriel Y, Gilbert TJ, Mehbod AA, Denis F, Transfeldt EE, Wroblewski JM. Clinical and radiological outcome of anterior-posterior fusion versus transforaminal lumbar interbody fusion for symptomatic disc degeneration: a retrospective comparative study of 133 patients. Eur Spine J. 2009 Feb;18(2):203-11. doi: 10.1007/s00586-008-0845-0. Epub 2009 Jan 6.

  PMID: 19125304 RESULT

• Hee HT, Castro FP Jr, Majd ME, Holt RT, Myers L. Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors. J Spinal Disord. 2001 Dec;14(6):533-40. doi: 10.1097/00002517-200112000-00013.

  PMID: 11723406 RESULT

• Levin JM, Tanenbaum JE, Steinmetz MP, Mroz TE, Overley SC. Posterolateral fusion (PLF) versus transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis: a systematic review and meta-analysis. Spine J. 2018 Jun;18(6):1088-1098. doi: 10.1016/j.spinee.2018.01.028. Epub 2018 Feb 13.

  PMID: 29452283 RESULT

• Carreon LY, Glassman SD, Ghogawala Z, Mummaneni PV, McGirt MJ, Asher AL. Modeled cost-effectiveness of transforaminal lumbar interbody fusion compared with posterolateral fusion for spondylolisthesis using N(2)QOD data. J Neurosurg Spine. 2016 Jun;24(6):916-21. doi: 10.3171/2015.10.SPINE15917. Epub 2016 Feb 19.

  PMID: 26895529 RESULT

• Fujimori T, Le H, Schairer WW, Berven SH, Qamirani E, Hu SS. Does Transforaminal Lumbar Interbody Fusion Have Advantages over Posterolateral Lumbar Fusion for Degenerative Spondylolisthesis? Global Spine J. 2015 Apr;5(2):102-9. doi: 10.1055/s-0034-1396432. Epub 2014 Dec 1.

  PMID: 25844282 RESULT

• Ghasemi AA. Transforaminal lumbar interbody fusion versus instrumented posterolateral fusion In degenerative spondylolisthesis: An attempt to evaluate the superiority of one method over the other. Clin Neurol Neurosurg. 2016 Nov;150:1-5. doi: 10.1016/j.clineuro.2016.08.017. Epub 2016 Aug 21.

  PMID: 27565009 RESULT

• Owens RK 2nd, Carreon LY, Djurasovic M, Glassman SD. Relative benefit of TLIF versus PSF stratified by diagnostic indication. J Spinal Disord Tech. 2014 May;27(3):144-7. doi: 10.1097/BSD.0b013e3182867470.

  PMID: 24945292 RESULT

• Pooswamy S, Muralidharagopalan NR, Subbaiah S. Transforaminal lumbar interbody fusion versus instrumented posterolateral fusion in Grade I/II spondylolisthesis. Indian J Orthop. 2017 Mar-Apr;51(2):131-138. doi: 10.4103/0019-5413.201703.

  PMID: 28400657 RESULT

• Makanji H, Schoenfeld AJ, Bhalla A, Bono CM. Critical analysis of trends in lumbar fusion for degenerative disorders revisited: influence of technique on fusion rate and clinical outcomes. Eur Spine J. 2018 Aug;27(8):1868-1876. doi: 10.1007/s00586-018-5544-x. Epub 2018 Mar 15.

  PMID: 29546538 RESULT

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Aron Lazary, MD, PhD

  National Center for Spinal Disorders

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bálint Kozma

CONTACT

+3630 6861784; bkozma@sanatmetal.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, open-label clinical trial. This clinical investigation addresses to collect data on clinical performance, effectiveness and safety of Sanatmetál's ReSpace TiCell Cage in human subjects following the good clinical practice according to the Medical Device Regulation (MDR) \& EN ISO 14155:2020. The study is conducted in Hungary at National Center for Spinal Disorders.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)