Failed lumbar fusion MedDRA version: 20.0 Level: LLT Classification code 10050238 Term: Spinal fusion NOS System Organ Class: 100000021566
Conditions
Sponsors
Bone Therapeutics S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or woman aged of minimum 18 years old (at the time of treatment) -Diagnosed with a failed lumbar interbody fusion procedure at the time of ALLOB® treatment: - Defined radiologically (as judged by the Investigator) - Of a minimum of 15 months follow-up - Requiring a revision surgery at one or two level(s) between L1 to S1 - Capable to provide a written, dated, and signed informed consent and to understand and comply with the study requirements 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 4
Exclusion criteria
Exclusion criteria: Current symptoms and/or signs related to the disease under study - More than two previous spinal surgeries at the lumbar level(s) not involving instrumentation withdrawal - More than two failed interbody fusion at the involved lumbar level(s) - Local active or latent infection at the involved lumbar level(s) - Instrumentation failure (e.g., pedicle screw, interbody cage) requiring revision surgery - Extra-spinal cause of back pain, such as trauma, infection, or tumour at the involved lumbar level(s) - Requiring surgery within the next 12 months (at the time of the implantation) Current or previous diagnoses, signs and/or symptoms - Positive serology for HIV (defined as positive Anti-HIV 1 and/or 2 and/or positive PCR) - Active hepatitis B (defined as positive HBs Ag and/or positive PCR) - Active hepatitis C (defined as positive Anti-HCV and/or positive PCR) - Global sepsis - Severe renal (defined as a creatinine clearance value 8%) - Severe allergy or anaphylaxis - Known allergy to gentamicin - Known allergy to contrast agent (only in case of use of contrast agent during implantation procedure) - Medical condition that could interfere with study participant assessment (e.g., neuromuscular disease, psychiatric disease, paraplegia) - Active autoimmune disease (e.g., sclerodermia, Sjögren syndrome, lupus) - Current or past (within 5 years) malignant neoplasia (except for cured cancers such as non-metastatic thyroid cancer, seminoma, non-melanoma skin cancer…) - Poor general health or concomitant disease that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease) - History of organ or bone marrow transplantation - History of hypersensitivity to human biological material including blood and blood derived products, documented clinically or by laboratory tests Current or previous treatment - Previous treatment with ALLOB® - Participation (within 3 months of screening) in another clinical study involving a pharmacological agent - Current or past treatment (within 5 years of screening) for cancer or blood dyscrasia, including but not limited to chemotherapy, radiotherapy, immunotherapy, biotherapy, haematopoietic growth factors and/or anti-angiogenesis treatment (except for cured cancers such as non-metastatic thyroid cancer, seminoma, non-melanoma skin cancer..) - Current (within 6 months of screening) illicit drug abuse (as per local law) Safety aspects concerning female subjects with childbearing potential - Positive Urine Pregnancy test - Pregnancy - Breast-feeding - Woman with childbearing potential not willing or not able to use reliable contraceptive method for at least 6 weeks prior to screening and during the whole study period (reliable contraceptive methods include orally administered hormonal contraceptives, intrauterine device or surgical intervention (e.g., tubal ligation) Other exclusion criteria - Body Mass Index (BMI) = 35 kg/m2 - Clinically relevant abnormal ECG (>6-lead or according to standard of care at the hospital), as judged by the Investigator or any medically qualified member of the study care team - Unable to undergo general anaesthesia or a surgical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and efficacy of ALLOB® in rescue interbody fusion over 12 months in patients suffering from failed lumbar fusion at one or two level(s). Safety: At each visit, subjects will be assessed for the potential occurrence of any AE or SAE related to the product or to the procedure, using patient open non-directive questionnaires, vital signs and laboratory measurements. Efficacy: The efficacy of the treatment will be evaluated at Month 12: - Radiologically (progression of the lumbar fusion): the Fusion Score as assessed by CT-scan vs. baseline. - Clinically (functional disability): the changes in ODI 2.1a vs. baseline. ;Secondary Objective: The other efficacy endpoints are: -Number of patients requiring a rescue surgery for failed rescue fusion -Changes in ODI 2.1a at each FU visit -Changes in Back and Leg Pain VAS at each FU visit -Changes in Global Disease Evaluation VAS at each FU visit -Lumbar fusion progression using the Fusion Score at Month 6, 9, 12 -Mean time to lumbar fusion -Changes of intervertebral mobility at Month 6, 9, 12 -Integrity of instrumentation and surrounding bones at Month 6, 9, 12 -Changes of segmental lordosis at Month 6, 9, 12 -Changes of lumbar lordosis at Month 6, 9, 12 -Changes of disc height at Month 6, 9, 12 -Assessment of bone metabolism at each FU visit -Blood loss during procedure -Operating time -Number of per- and post-operative complications -Hospital stay duration -Assessment of ALLOB® biodistribution at Hour 4, 24, 48, 72 -Assessment of bone remodelling/formation at Month 3, 6, 9 ;Primary end point(s): Safety criteria: From the beginning to the end of the main study period at Month 12, study participants will be systematically assessed for the potential occurrence of any AE and SAE related or not to the treatment (i.e., ALLOB® or implantation procedure), using subject open questionnaires, physical examinations and laboratory measurements. Selected safety data will a | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The other endpoints will be: - Number (percentage) of patients requiring a rescue surgery for failed rescue fusion at one or more level(s) - Changes in ODI 2.1a at each follow-up visit (vs. baseline) - Changes in Back and Leg Pain VAS at each follow-up visit (vs. baseline) - Changes in Global Disease Evaluation VAS at each follow-up visit (vs. baseline) - Lumbar fusion progression at the treated level(s) using the Fusion Score as assessed by CT-scan at Month 6, 9 and 12 - Mean time to lumbar fusion at the treated level(s) as assessed by CT-scan - Changes of intervertebral mobility at the treated level(s) as assessed by X-ray at Month 6, 9 and 12 (vs. baseline) - Integrity of instrumentation and surrounding bones at the treated level(s) as assessed by CT-scan and X-ray at Month 6, 9 and 12 - Changes of segmental lordosis at treated level(s) as assessed by X-ray at Month 6, 9 and 12 (vs. baseline) - Changes of lumbar lordosis as assessed by X-ray at Month 6, 9 and 12 (vs. baseline) - Changes of disc height at the treated level(s) as assessed by CT-scan at Month 6, 9 and 12 (vs. baseline) - Assessment of bone metabolism using bone biomarkers at each follow-up visit (vs. baseline) - Loss of blood during procedure - Operating time - Number of per-operative and post-operative complications - Duration of hospital stay - Assessment of ALLOB® biodistribution at Hour 4, 24, 48 and 72 - Assessment of bone remodelling/formation at Month 3, 6 and 9 (vs. baseline);Timepoint(s) of evaluation of this end point: Efficacy endpoints will be determined at each scheduled visit over the 12-month follow-up period. | — |
Countries
Belgium
Contacts
Public ContactClinical Trial Information
Bone Therapeutics S.A.
Outcome results
None listed