Performance and safety Clinical study on JULIET®TI LL cage in fusion lumbar spinal surgery
| ISRCTN | ISRCTN12002403 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12002403 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | JULIET Ti LL / P77_CLD001 |
| Sponsor | Spineart (Switzerland) |
| Funder | Spineart SA |
- Submission date
- 13/04/2022
- Registration date
- 12/05/2022
- Last edited
- 19/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Degenerative disc disease (DDD) in the lumbar spine (lower back) occurs when age-related wear and tear on a spinal disc causes low back pain. Surgery for lumbar DDD is recommended when non-surgical treatment fails. There are different surgical techniques for lumbar fusion. One of them is the lateral approach, called lumbar lateral interbody fusion (LLIF). LLIF is a minimally invasive surgery to treat disc problems causing pain in the low back. In spinal fusion, two or more vertebrae (bones) of the spine are joined to stop painful motion and to decompress pinched nerves. Through a small incision at the side of the waist, the damaged disc is removed and replaced with a spacer. The spacer (also called a cage) restores the height between the bones and relieves pinching of the spinal nerves. The cage becomes a bridge between the two bones and is filled with bone graft to promote fusion. In some cases, the cage is strengthened with a plate and screws on the side or with pedicle screws from the back. This study aims to confirm the performance and safety of the Spineart lateral cage: Juliet Ti LL. The study's findings should help to improve the well-being of future patients with lumbar DDD.
Who can participate?
Patients aged 18 years and over, scheduled for lateral lumbar interbody fusion surgery
What does the study involve?
The surgery and the majority of the follow-up visits/exams are part of routine care. The study lasts 2 years in total, with a preoperative visit, the surgery, and 3-, 6-, 12- and 24-month postoperative visits. Participants also complete online questionnaires during the study period.
What are the possible benefits and risks of participating?
There are no anticipated personal benefits for the patients besides achieving fusion and reducing pain. In addition to the routine procedures, the radiologic exams used for this study include up to two CT scans at 12 and 24 months after surgery. They may be an ionization risk for the additional exams.
Where is the study run from?
Spineart (Switzerland)
When is the study starting and how long is it expected to run for?
March 2021 to November 2024
Who is funding the study?
Spineart (Switzerland)
Who is the main contact?
clinic@spineart.com
Contact information
Scientific
3, chemin du Pré Fleuri
Plan-les-Ouates
1228
Switzerland
| Phone | +41 (0)225701261 |
|---|---|
| dbermingham@spineart.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective interventional single-arm multicenter study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Prospective evaluation of clinical and radiographic outcomes after lumbar lateral interbody fusion surgery using a JULIET® Ti LL interbody fusion cage |
| Study acronym | Juliet Ti LL |
| Study objectives | The sample size of 71 study participants allows for detection of the primary endpoint of 90% in the target population with 80% power at two-sided 5% significance. |
| Ethics approval(s) | 1. Approved 30/07/2021, CPP Ile de France VII (CHU de Bicètre, 78 rue du Général Leclerc, 94275 le Kremlin Bicètre Cedex, France; +33 (0)1 45 21 28 46; cpp.idf.7-bicetre@wanadoo.fr), ref: 2021-A01537-34 2. Approved 29/03/2022, CEIM - Hospital Universitario Y Politécnico La Fe (Instituto de Investigación Sanitaria La Fe, Torre A – Planta 7ª – Despacho 7.02, Avenida Fernando Abril Martorell, 106, 46026 Valencia, Spain; +34 (0)96 124 66 05; ceic@iislafe.es), ref 520 3. Approved 05/01/2023, Ethik Kommission der Ärztekammer Westfalen-Lippe und der Westfällischen Wilhelms-Universität (Gartenstrasse 201-214, 48147 Münster, Germany; +49 (0)251 929 2460; ethhik-kommision@aekwl.de), ref: 2022-580-f-S |
| Health condition(s) or problem(s) studied | Patients with symptomatic degenerative lumbar disc diseases (DDD) and spondylosisthesis, functionally disabling discogenic low back pain that does not improve after conservative care |
| Intervention | The JULIET® Ti LL intervertebral implant is indicated for degenerative disk disease (DDD) and spondylosis causing chronic low back pains resistant to conservative management and when a surgical intervention with fusion technique is needed. Fusion consists of uniting one or more vertebrae of the spine together so that motion no longer occurs between them, eliminating instability. The JULIET® Ti LL interbody devices are to be used with autogenous and/or allogenic bone graft to facilitate fusion. The approach technique is lateral lumbar interbody fusion (LLIF) which is minimally invasive and involves accessing the disc space via a lateral retroperioneal, transpsoas or pre-psoas corridor. The study duration for the enrollment period is estimated to be 9 months and each patient should be followed up to 24 months postoperatively. |
| Intervention type | Device |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | JULIET® Ti LL Lateral cage |
| Primary outcome measure(s) |
The interbody fusion performance of JULIET® Ti LL system measured by spine CT scan within 24 months postoperatively |
| Key secondary outcome measure(s) |
1. Subsidence assessed with standing neutral lateral x-rays at 3-, 6-, 12- and 24-months postoperative visits |
| Completion date | 15/11/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 71 |
| Total final enrolment | 74 |
| Key inclusion criteria | 1. Skeletally mature subjects, ≥18 years old 2. Indicated DDD defined as discogenic back pain with degeneration of the disc confirmed radiographically and by patient history 2.1. DDD, or 2.2. DDD with up to grade I Spondylolisthesis, or 2.3. DDD with up to grade I Retrolisthesis 3. Psychosocially, mentally, and physically able to fully comply with the protocol including adhering to follow-up schedule and filling out questionnaires. 4. Written voluntary informed consent signed |
| Key exclusion criteria | 1. Mental illness 2. Infection 3. Severely damaged bone structures that could prevent stable implantation of the cage (bone density in SD ≤-2.5) 4. Neuromuscular or vascular disorders or illness 5. Inadequate activity (inability to follow postoperative rehab restriction) 6. Pregnancy 7. Bone tumor in the region of the implant 8. Fractures (same level treated or adjacent level: active, non-consolidated, or old osteoporotic fracture) |
| Date of first enrolment | 18/03/2022 |
| Date of final enrolment | 15/11/2023 |
Locations
Countries of recruitment
- France
- Germany
- Spain
Study participating centres
Versailles
78000
France
140 Rue André Lwoff
Saint-Priest
69800
France
Av. de la Generalitat Valenciana, 50
Manises, Valencia
46940
Spain
Werne
59368
Germany
Sainte-Colombe
69560
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/02/2024: The following changes were made to the study record:
1. Germany was added to the countries of recruitment.
2. The overall study end date was changed from 15/11/2024 to 15/11/2025.
3. The intention to publish date was changed from 31/12/2025 to 31/12/2026.
4. Clinique Trénel was added as a study participating centre.
5. Total final enrolment and ethics approval details added.
12/02/2024: The following changes were made:
1. The recruitment end date was changed from 31/12/2022 to 15/11/2023.
2. The study participating centre St. Christophorus Krankenhaus was added.
19/04/2022: Trial's existence confirmed by CPP Ile de France VII
