An interventional study of Topping off system and monosegmental PLIF in Spondylolisthesis and Erosive Osteochondrosis in L2-S1, sponsored by University of Cologne. Status unknown at 1 site in Germany. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2010-10-20.
Sponsored by University of Cologne · Not applicable, Interventional, and Treatment
Among 15 studies in Spondylolisthesis with a site in Germany — 1 open to participants now, 3 under way, none of them phase 3. Spondylolisthesis · Germany.
Among the 15 studies in Spondylolisthesis with a site in Germany, this one is the only one that started in 2011, is one of 5 with no phase, and was the 2nd registered.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
Browse Spondylolisthesis studies →1 of the 15 studies in Spondylolisthesis with a site in Germany is open now. Recruiting first, the newest first:
ZygoFix · Sites in Germany, Italy
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 27 Spondylolisthesis studies recruiting now, 11 (41%) set no upper age limit and 8 (30%) stop at 75 or younger; 7 take children under 18; 3 take healthy volunteers.
This study: 30 Years and older · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2011.
This study's planned enrollment of 30 is below the median of 60 across 143 interventional studies indexed under Spondylolisthesis.
Median enrollment 30 across the 6 interventional studies, 101 across the 9 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
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9 of 15 have an industry lead sponsor. The 8 most frequent:
University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.
University of Cologne has 2 studies filed under Spondylolisthesis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Spondylolisthesis with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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?
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):
Assessment of safety:
Key inclusion criteria:
Key exclusion criteria:
-
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
Device: Topping off system
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
Device: monosegmental PLIF
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
Also known as: Topping off
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
SF36
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).
Time frame: 6 Month
1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36
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
Time frame: 6 weeks
Safety
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
Time frame: all time
Individual dimensions of the Oswestry Disability Index (ODI)
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 frame: 6weeks
Time until radiological adjacent instability and comparison to the clinical outcome
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
Time frame: 6 weeks
Capacity of work at the time of surgery and after surgery, time until return to work
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
Time frame: 6 weeks
The record gives a start of Jan 2011, a primary completion of Jul 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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