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

Not Applicable

• Conditions: Spondylolisthesis; Erosive Osteochondrosis in L2-S1
• Interventions: Device: Topping off system; Device: monosegmental PLIF

• Registration Number: NCT01224379
• Lead Sponsor: University of Cologne

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

Study Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-19
• Last Update Submitted: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Posted: 2010-10-20
• Study Start: 2011-01
• Primary Completion: 2012-07
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1: "topping off" system	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).
Arm 2: monosegmental PLIF	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)

Primary Outcome Measures

Name	Time	Method
SF36	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).

Secondary Outcome Measures

Name	Time	Method
1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36	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	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)	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	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	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

Trial Locations

Locations (1)

University of Cologne, Department of Orthopedics& traumasurgery; 🇩🇪 Cologne, Germany