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):
- Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36
- Individual dimensions of the Oswestry Disability Index (ODI)
- Time until radiological adjacent instability and comparison to the clinical outcome
- Capacity of work at the time of surgery and after surgery, time until return to work
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
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:
- 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
- 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