Trial document
DRKS00006865
Trial Description
Title
Randomized clinical trial to prove the effectiveness of a spine orthosis (Spinova Support Plus by Bauerfeind) for the postoperative treatment after lumbar spinal fusion of one or two segments in L3-S1 due to degenerative lumbar spine desease
Trial Acronym
AWB/Spinova-01
URL of the Trial
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Brief Summary in Lay Language
Before doing a fusion of the lower lumbar spine, patients are classified into two groups by chance. One group receives a spine orthosis (Spinova Support Plus by Bauerfeind) after surgery for supporting the rehabilition, the other one doesn't. During rehabilitation the clinical outcome is measured by questionaires and the endurance of the back muscles is measured by a surface elektromyogramm.
Brief Summary in Scientific Language
This is a randoized clinical trial for the postoperative treatment after lumbar spinal fusion of one or two segments in L3-S1 due to degenerative lumbar spine desease. One group receives a spine orthosis (Spinova Support Plus by Bauerfeind), the other one doesn't. In both groups the clinical outcome is measured by questionaires (Oswestry Disability Index, VAS, patient satisfaction). In addition an surface electromyogramm is done for diagnosing the fatigue index of the erector spinae.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00006865
- 2014/10/13
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- no
- Approved
- 381/13, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
Secondary IDs
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Health Condition or Problem studied
- M53.26 - [generalization M53.2: Spinal instabilities]
- M42.16 - [generalization M42.1: Adult osteochondrosis of spine]
- M43.16 - [generalization M43.1: Spondylolisthesis]
- M47.86 - [generalization M47.8: Other spondylosis]
- M48.06 - [generalization M48.0: Spinal stenosis]
Interventions/Observational Groups
- Additional to the standard postoperative treatment, patients receive a spinal orthosis (Spinova Support Plus by Bauerfeind) for 12 weeks after surgery. After 6 weeks the bridging pad of the orthesis is removed.
- The patients receive standard postoperative treatment after surgery without orthosis.
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control
- Supportive care
- Parallel
- N/A
- N/A
Primary Outcome
Primary aim is to prove the additional benefit of a spine othosis after lumbar fusion.
To demonstrate the difference in the postoperative treatment, all patients of both groups receive questionaires about their aktivities of daily living (Oswestry Disability Index), about pain (visual analogue scale) and about the satisfaction (very satisfied, satisfied, largely satisfied, partially satisfied, rarely satisfied, not satisfied) before surgery and at the time of discharge. Patients receive further questionaires 6 weeks, 12 weeks, 6 months and 12 months after surgery.
Secondary Outcome
Secondary aim is to show a better endurance of the erector spinae in the group of patients, who receive a spinal orthosis.
To prove that assumption, the muscle fatigue index is derived fom a surface EMG of the erector spinae at all patients of both groups before surgery and at the time of discharge, 6 weeks and 12 weeks after surgery.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Planned
- 2014/10/10
- 50
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 25 Years
- no maximum age
Additional Inclusion Criteria
Patients after lumbar spinal fusion of one or two segments in L3-S1 due to degenerative lumbar spine desease
Exclusion Criteria
Age <25; Patients, who cannot give their consent; breast feeding, pregnant women or women, who plan to get pregnat during the clinical trail; Patients with walking disability due to osteoarthritis III° and more; systemic neurological desease with limited mobility, e.g. Parkinson's desease or multiple sclerosis; Patients with intolerance or known limitations, that make the participation of the clinical trial impossible.
Addresses
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start of 1:1-Block address primary-sponsor
- Firma Bauerfeind AG
- Mr. Dr. Uwe Berendt
- Triebeser Str. 16
- 07937 Zeulenroda–Triebes
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +4936628661720
- +4936628/661718
- uwe.berendt at bauerfeind.com
- http://www.bauerfeind.com
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- Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn
- Mr. Dr. Yorck Rommelspacher
- Sigmund Freud Str. 25
- 53127 Bonn
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +4922828714176
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- yorck.rommelspacher at ukb.uni-bonn.de
- http://www.ortho-unfall-bonn.de
end of 1:1-Block address contact scientific-contact -
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- Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn
- Mr. Dr. Yorck Rommelspacher
- Sigmund Freud Str. 25
- 53127 Bonn
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +4922828714176
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- yorck.rommelspacher at ukb.uni-bonn.de
- http://www.ortho-unfall-bonn.de
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Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Firma Bauerfeind AG
- Triebeser Straße 16
- 07937 Zeulenroda-Triebes
- Germany
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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