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

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

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Stenosis
• Intervention / Treatment: Device: Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uwe Spetzger, Prof; Phone Number: +497219740; Email: uwe.spetzger@klinikum-karlsruhe.de
• Study Contact Backup: Name: Andreas Veihelmann, Prof; Phone Number: 4023 +497083926; Email: andreas.veihelmann@sportklinik-stuttgart.de

Study Locations

• Germany
  • Karlsruhe, Germany, 76133
    • Recruiting
    • Klinikum Karlsruhe
    • Contact: Uwe Spetzger; Phone Number: +497219740; Email: uwe.spetzger@klinikum-karlsruhe.de
    • Contact: Andreas Veihelmann; Phone Number: +497083926; Email: andreas.veihelmann@sportklinik-stuttgart.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group "without lumbar belt"
Experimental: Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo; Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo	Device: Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo; Wear for 6 weeks post-surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate or reherniation/restenosis by means of MRI results	symptomatic reduction of Walking distance	at 104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SRH Gesundheitszentrum Bad Herrenalb
• Investigators: Study Chair: Andreas Veihelmann, Prof, SRH Ges.-Zentrum Bad Herrenalb

Study record dates

Study Major Dates

• Study Start (Anticipated): June 28, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: GBH-O1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No