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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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

Sponsor: University of Cologne

Current Primary Outcome: SF36 [ Time Frame: 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).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: University of Cologne

Dates:
Date Received: October 19, 2010
Date Started: January 2011
Date Completion: October 2012
Last Updated: October 19, 2010
Last Verified: September 2010