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

Not Applicable

Recruiting

Conditions: M53.26
M42.16
M43.16
M47.86
M48.06

Registration Number: DRKS00006865

Lead Sponsor: Firma Bauerfeind AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary aim is to prove the additional benefit of a spine othosis after lumbar fusion.<br>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 Measures

Name	Time	Method
Secondary aim is to show a better endurance of the erector spinae in the group of patients, who receive a spinal orthosis.<br>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.