Evidence For Fusion In Spine With Orthoss®

Lumbar Spinal Stenosis Clinical Trial

— EFFISO  

Official title:

Evidence For Fusion In Spine With Orthoss®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03853356
• Other study ID #: 13570-222
• Status: Recruiting
• Start date: January 18, 2019
• Est. completion date: January 2026

Study information

• Verified date: February 2023
• Source: Geistlich Pharma AG
• Contact: Nina Schnüriger
• Phone: +41 41 492 68 37
• Email: nina.schnueriger[@]geistlich.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).

Description:

This clinical investigation is a prospective, non-interventional, uncontrolled clinical trial, organized to generate clinical data on performance and safety of Orthoss® as a bone graft extender mixed with local bone at ratio of 1:1 and pedicle bone marrow aspirate in lumbar spondylodesis involving 1-2 levels. (Orthoss® is CE marked for this indication).

If you as a patient have a wear and tear disease of the spine, an operation serves to restore the stability of the spinal column. In order to promote a bony build-up of the lumbar spine segment (fusion), bone replacement material is used in your case as standard. The aim of this observational study is to determine fusion in order to address clinical performance of that bone replacement material.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: January 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient (male or female) must be 18 years or older

• The patient must be a candidate diagnosed with either degenerative disc disease including 1-2 level (L4-L5 and/or L5-S1) or dysplasic spondylolisthesis (degree 1 or 2) or lumbar stenosis

• If the patient is of child-bearing potential, the patient confirms not to be pregnant

• The patient is able to comply with the clinical investigation-related procedures such as attending all follow-up procedures

• The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent including the use of the anonymized data for scientific publication

• The patient will not participate in another clinical investigation during this clinical investigation

Exclusion Criteria:

• General contraindications for surgical treatment are present

• The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years

• The patient is currently being treated with radiation, chemotherapy, immunosuppression or steroid therapy dose equivalent of more than 5mg prednisolon

• The patient is pregnant or nursing

• Women of childbearing age who are not using a highly effective method of birth control

• The patient has acute or chronic infection at the surgical site

• The patient has a known allergy to bovine bone material

• The patient has a medical history of alcohol or drug abuse within the last year prior to the screening examination

• Vulnerable population

• Patient is currently participating, or has participated in another clinical investigation within 6 months

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Disc Degeneration
• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis Involving L4-L5
• Lumbar Spondylolisthesis Involving L5-S1
• Spinal Stenosis
• Spondylolisthesis

Intervention

Device:
• Orthoss
Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik	Augsburg
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Klinikum Magdeburg gGmbH	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
Geistlich Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion rate	Successful fusion should be based on the translational motion < 3mm as well as on the angular motion < 5° at 6 months.	6 months
Secondary	Clinical Outcome Measure - Quality of Life: Oswestry Low Back Disability Index	Improvement in Oswestry Low Back Disability Index (ODI) of 15 or more at 24 months from the pre-operative value.Zero is equated with no disability and 100 is the maximum disability possible.	1-4 weeks; 3, 6, 12 and 24 months
Secondary	Clinical Outcome Measure - Leg pain	Decrease in Visual Analog Scale for Pain (VAS) for leg by 3/10 or more at 24 months from the pre-operative value. Patients rated their leg pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score fo 10 representing "pain as bad as it could be".	1-4 weeks, 3,6,12 and 24 months
Secondary	Clinical Outcome Measure - Back pain	Decrease in Visual Analog Scale for Pain (VAS) for back by 3/10 or more at 24 months from the pre-operative value. Patients rated their back pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score fo 10 representing "pain as bad as it could be".	1-