Universität zu Köln

Siewe, Jan, Bredow, Jan, Oppermann, Johannes, Koy, Timmo, Delank, Stefan, Knoell, Peter, Eysel, Peer, Sobottke, Rolf, Zarghooni, Kourosh ORCID: 0000-0001-7069-6291 and Roellinghoff, Marc (2014). Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial. BMC Musculoskelet. Disord., 15. LONDON: BMC. ISSN 1471-2474

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Abstract

Background: The 360 fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, topping off). However, its clinical significance is still uncertain due to the lack of conclusive data. Methods/ Design: The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + topping off), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year. Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI Ostwestry Disability Index, SF-36 (TM) - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters 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 (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. Discussion: New hybrid topping off systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. Trial registration: NCT01852526

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Siewe, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Bredow, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Oppermann, Johannes UNSPECIFIED UNSPECIFIED UNSPECIFIED Koy, Timmo UNSPECIFIED UNSPECIFIED UNSPECIFIED Delank, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Knoell, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Eysel, Peer UNSPECIFIED UNSPECIFIED UNSPECIFIED Sobottke, Rolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Zarghooni, Kourosh UNSPECIFIED orcid.org/0000-0001-7069-6291 UNSPECIFIED Roellinghoff, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-428956
DOI:	10.1186/1471-2474-15-294
Journal or Publication Title:	BMC Musculoskelet. Disord.
Volume:	15
Date:	2014
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; CLINICALLY IMPORTANT DIFFERENCE; OSWESTRY DISABILITY INDEX; SWEDISH-LUMBAR-SPINE; LOW-BACK-PAIN; DYNAMIC STABILIZATION; NONSURGICAL TREATMENT; SURGICAL-TREATMENT; SURGERY; OUTCOMES Multiple languages Orthopedics; Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42895