Clinical trial NCT01224379: Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
Official title: Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spondylolisthesis
Erosive Osteochondrosis in L2-S1
Keywords: Lumbar spine
fusion
adjacent instability
topping-off.
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

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Primary outcomes:
measure: SF36
timeFrame: 6 Month
Secondary outcomes:
measure: 1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36
timeFrame: 6 weeks
measure: Safety
timeFrame: all time
measure: Individual dimensions of the Oswestry Disability Index (ODI)
timeFrame: 6weeks
measure: Time until radiological adjacent instability and comparison to the clinical outcome
timeFrame: 6 weeks
measure: Capacity of work at the time of surgery and after surgery, time until return to work
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, Department of Orthopedics& traumasurgery
Study officials:
affiliation: University of Cologne
name: Jan Siewe, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siewe J, Otto C, Knoell P, Koriller M, Stein G, Kaulhausen T, Eysel P, Zarghooni K, Franklin J, Sobottke R. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2011 Oct 18;12:239. doi: 10.1186/1471-2474-12-239.