Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine (Topping-off)
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ClinicalTrials.gov Identifier: NCT01224379 |
Recruitment Status : Unknown
Verified September 2010 by University of Cologne.
Recruitment status was: Not yet recruiting
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spondylolisthesis Erosive Osteochondrosis in L2-S1 | Device: Topping off system Device: monosegmental PLIF | Not Applicable |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | January 2011 |
Estimated Primary Completion Date : | July 2012 |
Estimated Study Completion Date : | October 2012 |
Arm | Intervention/treatment |
---|---|
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).
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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)
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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) |
- 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).
- 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

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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224379
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 |
Germany | |
University of Cologne, Department of Orthopedics& traumasurgery | |
Cologne, Germany, 50931 | |
Contact: Jan Siewe, Dr. +49-221-478-87294 studienzentrum-ortho-unfall@uk-koeln.de | |
Principal Investigator: Jan Siewe, Dr. |
Principal Investigator: | Jan Siewe, Dr. | University of Cologne |
Responsible Party: | University of Cologne, Medizinische Fakultät der Universität zu Köln |
ClinicalTrials.gov Identifier: | NCT01224379 |
Other Study ID Numbers: |
Uni-Köln-1223 Uni-Köln-1223 ( Other Grant/Funding Number: University of Cologne ) |
First Posted: | October 20, 2010 Key Record Dates |
Last Update Posted: | October 20, 2010 |
Last Verified: | September 2010 |
Lumbar spine fusion adjacent instability topping-off. |
Spondylolisthesis Osteochondrosis Spondylolysis Spondylosis |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |