Universität zu Köln

Siewe, Jan, Otto, Christina, Knoell, Peter, Koriller, Marco, Stein, Gregor ORCID: 0000-0002-0443-4573, Kaulhausen, Thomas, Eysel, Peer, Zarghooni, Kourosh ORCID: 0000-0001-7069-6291, Franklin, Jeremy ORCID: 0000-0003-1536-0925 and Sobottke, Rolf (2011). Comparison of standard fusion with a topping off system in lumbar spine surgery: a protocol for a randomized controlled trial. BMC Musculoskelet. Disord., 12. LONDON: BMC. ISSN 1471-2474

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Abstract

Background: Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. Topping off systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence that these devices provide any patient benefits. Methods/Design: The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment (topping off). Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually. Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36 (TM), ODI, COMI). In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided. Discussion: New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these topping off systems. High quality data is required to evaluate the benefits and drawbacks of topping off devices. If only because these devices are quite expensive compared to conventional fusion implants, nonessential use should be avoided. In fact, these high costs necessitate efforts by health care providers to evaluate the effects of these implants. Randomized clinical trials are highly recommended to evaluate the benefits or harm to the patient.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Siewe, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Otto, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Knoell, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Koriller, Marco UNSPECIFIED UNSPECIFIED UNSPECIFIED Stein, Gregor UNSPECIFIED orcid.org/0000-0002-0443-4573 UNSPECIFIED Kaulhausen, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Eysel, Peer UNSPECIFIED UNSPECIFIED UNSPECIFIED Zarghooni, Kourosh UNSPECIFIED orcid.org/0000-0001-7069-6291 UNSPECIFIED Franklin, Jeremy UNSPECIFIED orcid.org/0000-0003-1536-0925 UNSPECIFIED Sobottke, Rolf UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-487183
DOI:	10.1186/1471-2474-12-239
Journal or Publication Title:	BMC Musculoskelet. Disord.
Volume:	12
Date:	2011
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1471-2474
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ADJACENT SEGMENT DEGENERATION; LOW-BACK-PAIN; OSWESTRY DISABILITY INDEX; NONSURGICAL TREATMENT; STABILIZATION; DISEASE; OSTEOARTHRITIS; MULTICENTER; OUTCOMES Multiple languages Orthopedics; Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48718