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

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

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?

Study Overview

• Status: Unknown
• Conditions: Spondylolisthesis; Erosive Osteochondrosis in L2-S1
• Intervention / Treatment: Device: Topping off system; Device: monosegmental PLIF

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Siewe, Dr.; Phone Number: +49-221-478-87294; Email: studienzentrum-ortho-unfall@uk-koeln.de
• Study Contact Backup: Name: Margarete Wicharz; Phone Number: +49-221-478-87294; Email: studienzentrum-ortho-unfall@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 50931
    • University of Cologne, Department of Orthopedics& traumasurgery
    • Contact: Jan Siewe, Dr.; Phone Number: +49-221-478-87294; Email: studienzentrum-ortho-unfall@uk-koeln.de
    • Principal Investigator: Jan Siewe, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm1: "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: 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).; Other Names: Topping off
Other: Arm 2: 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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Jan Siewe, Dr., University of Cologne

Publications and helpful links

General Publications

• Siewe J, Otto C, Knoell P, Koriller M, Stein G, Kaulhausen T, Eysel P, Zarghooni K, Franklin J, Sobottke R. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2011 Oct 18;12:239. doi: 10.1186/1471-2474-12-239.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: October 19, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (Estimate): October 20, 2010

Study Record Updates

• Last Update Posted (Estimate): October 20, 2010
• Last Update Submitted That Met QC Criteria: October 19, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Lumbar spine; fusion; adjacent instability; topping-off.
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis; Osteochondrosis
• Other Study ID Numbers: Uni-Köln-1223 (Other Grant/Funding Number: University of Cologne)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No