Post-market clinical follow-up study with the cyclOS Putty
- Conditions
- Bone defect filling or bony fusion of the skeletal system
- Registration Number
- DRKS00027519
- Lead Sponsor
- Mathys AG Bettlach
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 17
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
o Minors (< 18 years) at inclusion
o Patients with age >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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).