Post-market clinical follow-up study with the cyclOS Putty
Organizational Data
- DRKS-ID:
- DRKS00027519
- Recruitment Status:
- Recruiting stopped (after recruiting started)
- Date of registration in DRKS:
- 2022-10-24
- Last update in DRKS:
- 2023-05-17
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
Brief summary in lay language
Spine fusions are often the best solution for various degenerative conditions. Lumbar interbody fusion (LIF) is usually performed with interbody cages filled and surrounded with graft material. The aim of this study is to investigate the fusion rate of bone substitute "cyclOS Putty" assesssed with X-ray analysis.
Brief summary in scientific language
Spine fusions are often the best solution for various degenerative conditions. Lumbar interbody fusion (LIF) is usually performed with interbody cages filled and surrounded with graft material, placed within the intervertebral space after discectomy and endplate preparation, and supported with metallic screws and rods/plates to assist the fusion of adjacent vertebrae. This procedure requires adequate fixation to immobilize the treated section of the spine while the bone graft supports fusion of the vertebral segments. Out of the various synthetic materials, β-tricalcium phosphate (β-TCP) is widely used in spine indications. Since β-TCP has osteoconductive but no osteoinductive properties, it is often augmented with biologically active materials such as bone marrow, growth factors or autologous bone grafts. The aim of this study is to investigate the fusion rate of the kneadable β-TCP bone substitute “cyclOS Putty” assessed with dynamic X-ray 12 month post-operatively in patients treated with transforaminal lumbar interbody fusion (TLIF).
Health condition or problem studied
- Free text:
- Bone defect filling or bony fusion of the skeletal system
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
Endpoints
- Primary outcome:
- 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:
- 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).
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting stopped (after recruiting started)
- Reason if recruiting stopped or withdrawn:
- Company decision, discontinuation of distribution of biomaterials
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Waldkliniken Eisenberg Eisenberg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2022-10-21
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-05-16
- Target Sample Size:
- 60
- Final Sample Size:
- 17
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 70 Years
- Additional 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
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)
Addresses
Primary Sponsor
- Address:
- Mathys AG Bettlach/ Monika LehmannRobert Mathys Strasse 52544 BettlachSwitzerland
- Telephone:
- /
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Waldkliniken Eisenberg GmbHProf. Dr. med. Patrick StrubeKlosterlausnitzer Strasse 8107607 EisenbergGermany
- Telephone:
- +49 36691 8 1439
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Waldkliniken Eisenberg GmbHProf. Dr. med. Patrick StrubeKlosterlausnitzer Strasse 8107607 EisenbergGermany
- Telephone:
- +49 36691 8 1439
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Waldkliniken Eisenberg GmbHProf. Dr. med. Patrick StrubeKlosterlausnitzer Strasse 8107607 EisenbergGermany
- Telephone:
- +49 36691 8 1439
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Mathys AG BettlachRobert Mathys Strasse 52544 BettlachSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Landesärztekammer ThüringenIm Semmicht 3307751 JenaGermany
- Telephone:
- +49-3641-614201
- Fax:
- +49-3641-614209
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-12-23
- Ethics committee number:
- 72376/2022/34
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-06-13
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- This is a monocentric study, sharing of participant-related data is not planned.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry