Degenerative disc disease MedDRA version: 20.0 Level: LLT Classification code 10070241 Term: Degenerative disc disease System Organ Class: 100000018941
Conditions
Sponsors
Bone Therapeutics S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or woman aged 18 to 75 years (inclusive) - Diagnosed with lumbar degenerative disc disease - Symptomatic with an ODI 2.1a score = 30 - Demonstrated radiologically - Requiring a single level lumbar fusion (L1 to S1) - Unresponsive to non-operative treatment (e.g., medication, physical therapy) for at least 6 months at the time of screening - 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Current symptoms and/or signs related to the disease under study - More than one previous spinal surgery at the involved lumbar level - Previous failed fusion at the involved lumbar level - Local active or latent infection at the involved lumbar level - Requiring surgery at more than one-level of the lumbar spinal region within the next 12 months - Diagnosis of non-union, fracture or tumour at the involved lumbar level - Diagnosis of multilevel scoliosis or adjacent segment syndrome at the lumbar spine - Diagnosis of high-grade isthmic/lytic spondylolisthesis (grade > III) requiring multi-level lumbar fusion Current or previous diagnoses, signs and/or symptoms - Highly communicable diseases (i.e., HIV, active hepatitis B or C (defined as positive HBs Ag and/or positive PCR), active tuberculosis, syphilis) - Global sepsis - Severe renal (defined as a creatinine clearance value 8%) - Severe allergy or anaphylaxis - Known allergy to gentamicin - Medical condition that can inhibit bone healing (e.g., severe osteoporosis (as defined by T-score 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 intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and efficacy of ALLOB® in spinal fusion over 12 months in spinal fusion in patients with symptomatic disc disease of the lumbar spine. Safety: Subjects will be systematically assessed for the potential occurence of any AE and SAE related or not to the treatment (i.e., ALLOB®/ß-TCP mix or surgical procedure), using subject open questionnaires, physical examinations and laboratory measurements. Efficacy: The efficacy of the treatment will be evaluated at Month 12: - clinically (functional disability): the improvement in ODI 2.1a vs. baseline visit -radiologically (progression of the lumbar fusion): the mean Lumbar Fusion Score as assessed by CT-scan.;Secondary Objective: -Number (%) of patients requiring a rescue surgery at Month 6, 9, 12 -Improvement in ODI 2.1a at each follow-up visit (vs. baseline visit) -Improvement in Back and Leg Pain VAS at each follow-up visit (vs. baseline visit) -Improvement in Global Disease Evaluation VAS at each follow-up visit (vs. baseline visit) -Lumbar fusion progression using the Lumbar Fusion Score as assessed by CT-scan at Month 3, 6, 12 (vs. baseline value) -Mean time to lumbar fusion as assessed by CT-scan -Evolution of the intervertebral mobility at Month 3, 6, 9, 12 (vs. baseline visit) -Integrity of instrumentation and surrounding bones at Month 3, 6, 9, 12 -Evolution of segmental lordosis at Month 3, 6, 9, 12 (vs. baseline visit) -Evolution of lumbar lordosis at Month 3, 6, 9, 12 (vs. baseline visit) -Evolution of disc height at Month 3, 6, 12 (vs. baseline value) -Loss of blood during procedure -Operating time -Number of per-operative and post-operative complications -Duration of hospital stay;Primary end point(s): Safety criteria: At each visit, subjects will be assessed for the potential occurence 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 criteri | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Efficacy endpoints will be determined at each scheduled visit over the 12-month follow-up period. ;Secondary end point(s): The other endpoints will be: - Number (percentage) of patients requiring a rescue surgery at Month 6, 9 and 12 - Improvement in ODI 2.1a at each follow-up visit (vs. baseline visit) - Improvement in Back and Leg Pain VAS at each follow-up visit (vs. baseline visit) - Improvement in Global Disease Evaluation VAS at each follow-up visit (vs. baseline visit) - Lumbar fusion progression using the Lumbar Fusion Score as assessed by CT-scan at Month 3, 6 and 12 (vs. baseline value) - Mean time to lumbar fusion as assessed by CT-scan - Evolution of the intervertebral mobility at Month 3, 6, 9 and 12 (vs. baseline visit) - Integrity of instrumentation and surrounding vertebral bones at Month 3, 6, 9 and 12 - Evolution of segmental lordosis at Month 3, 6, 9 and 12 (vs. baseline visit) - Evolution of lumbar lordosis at Month 3, 6, 9 and 12 (vs. baseline visit) - Evolution of disc height at Month 3, 6 and 12 (vs. baseline value) - Loss of blood during procedure - Operating time - Number of per-operative and post-operative complications - Duration of hospital stay | — |
Countries
Belgium
Contacts
Public ContactClinical Trial Information
Bone Therapeutics S.A.
Outcome results
None listed