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

Spondylolisthesis Clinical Trial

— Topping-off  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01224379
• Other study ID #: Uni-Köln-1223
• Secondary ID: Uni-Köln-1223
• Status: Not yet recruiting
• Phase: N/A
• First received: October 19, 2010
• Last updated: October 19, 2010
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: September 2010
• Source: University of Cologne
• Contact: Jan Siewe, Dr.
• Phone: +49-221-478-87294
• Email: studienzentrum-ortho-unfall[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erosive Osteochondrosis in L2-S1
• Spondylolisthesis

Intervention

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).
• 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)

Locations

Country	Name	City	State
Germany	University of Cologne, Department of Orthopedics& traumasurgery	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 Month	No
Secondary	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	6 weeks	No
Secondary	Safety	Assessment of safety: Treatment complication in control and intervention groups (SAE-management); 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	all time	Yes
Secondary	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	6weeks	No
Secondary	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	6 weeks	No
Secondary	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	6 weeks	No

External Links

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