NCT01224379

Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Conditions

• Spondylolisthesis
• Erosive Osteochondrosis in L2-S1

Interventions

Type	Name	Description
DEVICE	Topping 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).
DEVICE	monosegmental PLIF	The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-07-01
• Completion: 2012-10-01
• First posted: 2010-10-20
• Last updated: 2010-10-20

Locations

1 site across 1 country: Germany