Evidence For Fusion In Spine With Orthoss®

NCT03853356 | Active Not Recruiting

• 1 other identifier: 13570-222
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 3

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).

Conditions

Lumbar Spondylolisthesis Involving L4-L5; Lumbar Spondylolisthesis Involving L5-S1; Lumbar Spinal Stenosis; Lumbar Disc Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical Outcome Measure - Quality of Life: Oswestry Low Back Disability Index

  1-4 weeks; 3, 6, 12 and 24 months

• Clinical Outcome Measure - Leg pain

  1-4 weeks, 3,6,12 and 24 months

• Clinical Outcome Measure - Back pain

  1-

Study Arms (1)

Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1)

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.

Device: Orthoss

Interventions

Orthoss DEVICE

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

Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Orthoss® mixed with local bone and pedicle bone marrow aspirate in lumbar spondylodesis by using transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) techniques in the 1-2 levels.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geistlich Pharma AG: lead

Study Sites (3)

Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik

Augsburg, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Klinikum Magdeburg gGmbH

Magdeburg, Germany

Location

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Fabiana Martinelli

  Geistlich Pharma AG

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 25, 2019
• Study Start: January 18, 2019
• Primary Completion: July 17, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)