Erosive Osteochondrosis in L2-S1, Spondylolisthesis
Conditions
Keywords
Lumbar spine, fusion, adjacent instability, topping-off.
Brief summary
Does a new topping-off device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?
Detailed description
Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS). Key secondary endpoint(s): 1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 2. Individual dimensions of the Oswestry Disability Index (ODI) 3. Time until radiological adjacent instability and comparison to the clinical outcome 4. Capacity of work at the time of surgery and after surgery, time until return to work Assessment of safety: 1. Treatment complication in control and intervention groups (SAE-management) 2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias
Interventions
DEVICETopping off system
The intervention group will receive a topping off system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
DEVICEmonosegmental PLIF
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: 1. Male or female \>30 years of age 2. Lumbar spine pathology with indication for monosegmental PLIF 3. Radiological signs of a degeneration of the adjacent segment without instability Key
Exclusion criteria
1\. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SF36 | 6 Month | Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36 | 6 weeks | 1\. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline |
| Safety | all time | Assessment of safety: 1. Treatment complication in control and intervention groups (SAE-management) 2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias |
| Individual dimensions of the Oswestry Disability Index (ODI) | 6weeks | Individual dimensions of the Oswestry Disability Index (ODI) follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline |
| Time until radiological adjacent instability and comparison to the clinical outcome | 6 weeks | Time until radiological adjacent instability and comparison to the clinical outcome follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline |
| Capacity of work at the time of surgery and after surgery, time until return to work | 6 weeks | Capacity of work at the time of surgery and after surgery, time until return to work follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline |
Countries
Germany
Contacts
Primary ContactJan Siewe, Dr.
Backup ContactMargarete Wicharz
Outcome results
None listed