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

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 - AWB/Spinova-01

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006865

Enrollment

Registered

2014-10-13

Start date

2014-10-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Group 1: 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 o

Eligibility

Sex/Gender

All

Age

25 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients after lumbar spinal fusion of one or two segments in L3-S1 due to degenerative lumbar spine desease

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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

Germany

Contacts

Public ContactYorck Rommelspacher

Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn

yorck.rommelspacher@ukb.uni-bonn.de+4922828714176

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026