Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine (Topping-off)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Cologne.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of Cologne
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01224379
First received: October 19, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
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Purpose
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?
| Condition | Intervention |
|---|---|
|
Spondylolisthesis Erosive Osteochondrosis in L2-S1 |
Device: Topping off system Device: monosegmental PLIF |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Further study details as provided by University of Cologne:
Primary Outcome Measures:
- SF36 [ Time Frame: 6 Month ] [ Designated as safety issue: No ]
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:
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Topping off
|
|
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)
Other Name: 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):
- 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
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key inclusion criteria:
- Male or female >30 years of age
- Lumbar spine pathology with indication for monosegmental PLIF
- 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
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224379
Contacts
| Contact: Jan Siewe, Dr. | +49-221-478-87294 | studienzentrum-ortho-unfall@uk-koeln.de |
| Contact: Margarete Wicharz | +49-221-478-87294 | studienzentrum-ortho-unfall@uk-koeln.de |
Locations
| Germany | |
| University of Cologne, Department of Orthopedics& traumasurgery | Not yet recruiting |
| Cologne, Germany, 50931 | |
| Contact: Jan Siewe, Dr. +49-221-478-87294 studienzentrum-ortho-unfall@uk-koeln.de | |
| Principal Investigator: Jan Siewe, Dr. | |
Sponsors and Collaborators
University of Cologne
Investigators
| Principal Investigator: | Jan Siewe, Dr. | University of Cologne |
More Information
Additional Information:
No publications provided by University of Cologne
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Cologne, Medizinische Fakultät der Universität zu Köln |
| ClinicalTrials.gov Identifier: | NCT01224379 History of Changes |
| Other Study ID Numbers: | Uni-Köln-1223, Uni-Köln-1223 |
| Study First Received: | October 19, 2010 |
| Last Updated: | October 19, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Cologne:
|
Lumbar spine fusion adjacent instability topping-off. |
Additional relevant MeSH terms:
|
Osteochondrosis Spondylolisthesis Bone Diseases Musculoskeletal Diseases |
Spondylolysis Spondylosis Spinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013