Bone defect filling or bony fusion of the skeletal system
Conditions
Interventions
Group 1: CyclOS Putty used as bone graft substitute in TLIF surgery. Clinical and radiological follow-up will be performed at 6 and at 12 months after surgery.
Sponsors
Mathys AG Bettlach
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: o Age between 18 and 70 years at inclusion o Patients who need surgical treatment with TLIF at 1 or 2 adjacent levels between L3 and S1 due to chronic degenerative disease of the lumbar spine o The patient has given his/her written consent to participate after having been fully informed (informed consent of the patient) o The patient is willing to participate in the follow-up examinations mentioned
Exclusion criteria
Exclusion criteria: o Minors (70 at inclusion o Pregnant or breastfeeding women o Prisoners at inclusion o Incapacitated subjects (individuals who are not able to give informed consent due to a mental disability) o Patient considered particularly vulnerable to substances and/or materials used in the study o Patients in emergency situations preventing the patient from giving informed consent o Enrolment of the investigator, his/her family, employees (Mathys Ltd Bettlach / investigational site) and other prejudiced persons o Known or suspected non-compliance of eligibility criteria (e.g., drug or alcohol abuse) o Non-compliance with clinical investigation-related processes (such as diagnosis and therapy) o Current therapies using steroids and drugs that intervene in the calcium metabolism o Previous surgery on the same or adjacent level o Infection of the lumbar spine, past or present tumor of the lumbar spine, significant bony defect in the lumbar spine, or scoliosis o Diseases that significantly inhibit bone healing: osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease or renal insufficiency o Contraindications set out in the instruction for use (IFU)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the assessment of the fusion status assessed in routinely acquired flexion-extension radiographs using functional X-ray analysis (FXATM) technique 12 months after index surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint of the investigation is the assessment fusion status with FXA in routinely acquired radiographs at 6 months after index surgery and recording of patient reported outcome measures (PROMs). | — |
Countries
Germany
Contacts
Public ContactPatrick Strube
Waldkliniken Eisenberg GmbH
Outcome results
None listed