Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.

Spinal Stenosis Clinical Trial

— SURGIMMO  

Official title:

Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312281
• Other study ID #: GBH-O1
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2022
• Source: SRH Gesundheitszentrum Bad Herrenalb
• Contact: Uwe Spetzger, Prof
• Phone: +497219740
• Email: uwe.spetzger[@]klinikum-karlsruhe.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the benefit of wearing a lumbar orthosis after surgery for spinal stenosis. It will be evaluated if a post-surgery immobilization for 6 weeks with a lumbar orthosis reduces early recurrence, increases walking distance, decreases significantly faster pain and pain medication after surgery

Description:

Spinal stenosis and orthoses The study situation in this regard is very poor, high-quality level 1 studies are not available.

A study by Prateepavanich et al. from 2001 shows advantages in the therapy with lumbar orthoses in neurogenic spinal claudication in the context of conservative therapy (9). Regarding postoperative prescription, expert opinions have long diverged (10). Nevertheless, in a survey of North American spine surgeons, over 60% reported prescribing an orthosis postoperatively (11).

2 Aim of the study

The aim of this study is to show that patients after surgical decompression for lumbar spinal stenosis and patients after surgical sequestrectomy benefit from temporary postoperative immobilization using a lumbar orthosis.

To show that postoperative therapy with a lumbar orthosis prolongs walking distance and reduces early recurrence.

It will be shown that postoperative pain decreases significantly faster and thus pain medication can be reduced faster early postoperatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy. Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis.

• Age 20-80 years

• Pre-operative walking distance at least 100m

• Consent form signed by the patient

Exclusion Criteria:

• Fusion surgery or recurrent surgery

• Tumors of the spine

• Cervical spinal stenosis or myelopathy

• Rheumatoid arthritis or similar autoimmune disease

• Infection - request for a pension

• Dyspnea due to heart failure with limited walking distance

• Peripheral Arterial Occlusive Disease (PAOD)-

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

Device:
• Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Wear for 6 weeks post-surgery

Locations

Country	Name	City	State
Germany	Klinikum Karlsruhe	Karlsruhe

Sponsors (1)

Lead Sponsor	Collaborator
SRH Gesundheitszentrum Bad Herrenalb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate or reherniation/restenosis by means of MRI results	symptomatic reduction of Walking distance	at 104 weeks
Secondary	Pain and Disability Index	Visual analog scale (VAS) (visual analog scale of 0-10, 0 means no pain, 10 means extreme pain, we expect better outcome with Lombastab), Oswestry Disability Questionaire (german version scale of 0-50, 0 means no impairment at all, 50 means highest possible impairment, we expect lower impairment due to Lombastab)	At 0, 2, 6, 12, 24, 52 and 104 weeks