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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03853356
Other study ID # 13570-222
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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-
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