Evidence For Fusion In Spine With Orthoss®

Recruiting

• Conditions: Lumbar Spinal Stenosis; Lumbar Spondylolisthesis Involving L4-L5; Lumbar Disc Degeneration; Lumbar Spondylolisthesis Involving L5-S1
• Interventions: Device: Orthoss

• Registration Number: NCT03853356
• Lead Sponsor: Geistlich Pharma AG

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2019-01-18
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-07
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1)	Orthoss	All surgical procedures to be performed during this clinical trial are part of the routine procedures for lumbar spondylodesis by using transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) techniques in the 1-2 levels (L4-L5 and/or L5-S1). Patients will receive surgery according to standard procedures.

Primary Outcome Measures

Name	Time	Method
Fusion rate	6 months	Successful fusion should be based on the translational motion \< 3mm as well as on the angular motion \< 5° at 6 months.

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome Measure - Quality of Life: Oswestry Low Back Disability Index	1-4 weeks; 3, 6, 12 and 24 months	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.
Clinical Outcome Measure - Back pain	1-	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".
Clinical Outcome Measure - Leg pain	1-4 weeks, 3,6,12 and 24 months	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".

Trial Locations

Locations (3)

Klinikum Magdeburg gGmbH; 🇩🇪 Magdeburg, Germany

Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik; 🇩🇪 Augsburg, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany