M51 M48.06 M43.16
Conditions
Interventions
Group 1: Follow up times: 6 weeks, 6, 12 and 24 months after surgery.
PROMs during the two FUs: COMI back und SF-36
CRFs during the two FUs Arbeitsstatus, Medikation und Komplikationsaufkommen
Radiol
Sponsors
NGMedcial GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Study participants must meet the following criteria: 1. Presence of one or more indications 2. Age = 18 years, 3. Patient is capable of understanding the nature, significance and scope of the clinical trial (MPDG §28), 4. Failed conservative treatment for at least six months , 5. Patient information has been provided and all written consents of the patient are available.
Exclusion criteria
Exclusion criteria: Known contraindication to the use of MOVE®-P according to the IFU and legal requirements: 1. General acute or chronic systemic infections of the target segment (spondylodiscitis, pre- or paravertebral abscess), 2. Morbid obesity (BMI value =35), 3. Pregnancy, 4. Severe progression of osteoporosis or osteopenia proven by SCORE/MORES = 6 (increased risk of osteoporosis), 5. Allergy to the implant material (see imprint on the packaging), 6. Previous operations in the area of the lumbar spine, 7. Patient is not willing or able to follow postoperative instructions, 8. Tissue deficit that prevents good wound closure, 9. Bone anomalies which prevent the secure fixation of the screw (e. g. dysplastic pedicles), 10. Patients undergoing growth, 11. Any case not mentioned under indications, 12. Acute or chronic infections, 13. Spinal metastases, 14. Trauma, 15. Spondylolisthesis > grade 1 or resection of the facet joints, 16. Moderate and severe arthrosis (Fujiwara > type 2), 17. Endocrine or metabolic illnesses in the patient’s history which influence the bone and mineral metabolism, 18. Any medication known to potentially affect the healing of bone/soft tissue, 19. Cauda equina syndrome or neurogenic bladder or pelvic dysfunction, 20. Participation in another clinical trial, 30 days prior to surgery and until the end of observation period, 21. The patient has been detained in an institution by court or official order (MPDG §27).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: • How often and what types of complications occur? • What other unforeseen complications occur? • What is the number of reoperations? Performance: • Are the established indications according to IFU correct? • Usability (use of instruments, handling) Efficacy: • Radiological outcome (RoM, CoR, evidence for screw loosening) • Quality of life (SF-36) • COMI back • VAS back and VAS leg The clinical results before the surgery (preoperative) are compared with the results at the 6-month visit (postoperative) and presented in the interim report. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: • How often and what types of complications occur? • What other unforeseen complications occur? • What is the number of reoperations? Performance: • Are the established indications according to IFU correct? Efficacy: • Quality of life (SF-36) • COMI back • VAS back and VAS leg The clinical results before the surgery (preoperative) are compared with the results at the 24-month visit (postoperative) and presented in the final report. | — |
Countries
Germany
Contacts
Public ContactJan Siewe
Klinikum Leverkusen gGmbH
Outcome results
None listed