Rate of Bone Union After Surgery With Stand-alone Fibergraft

NCT07199075 | Not Yet Recruiting

• 1 other identifier: Fibergraft
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking. A common treatment is a type of back surgery called lumbar interbody fusion, which helps stabilize the spine. At the St. Maartenskliniek in the Netherlands, doctors have been using a special material called Fibergraft Bioactive Glass Putty for such surgeries since 2023. This material helps bones grow and heal, and it's placed inside the spine without needing extra bone from another part of the body. This study will look at how well this material works by evaluating how many patients' bones successfully healed after surgery using this material. It will also look at how patients feel and recover after the procedure

Conditions

Spine Degeneration; Spine Disorder; Spine Pain; Spine Fusion; Spine Fusion for Degenerative Spine Disease; Nerve Root Compress;Lumbosac; Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Interbody fusion status

  The primary outcome measure is the interbody fusion status determined by a regular lumbar spine CT scan protocol without additional radiation or contrast agents. The patients will be evaluated with one CT-scan within a window of 12 to 24 months postsurgery. The Bridwell Interbody Fusion Grading Classification will be used to assess fusion status for each intended segment.

  12months to 24th months after index surgery

Secondary Outcomes (6)

• Oswestry Disability Index (ODI)

  Before the index surgery and 12-24months post index surgery

• General back pain and (worse side) leg pain

  Before the index surgery and 12-24 months after the index surgery

• The EuroQoL-5 Dimension

  Before the index surgery and 12-24months after the index surgery

• Patient's overall satisfaction

  12months to 24th months after the index surgery

• Complications

  From after the index surgery until the visit at 12months to 24months after the index surgery

Interventions

Questionnaires BEHAVIORAL

Questionnaires * Oswestry Disability Index (ODI) * Pain NRS lower back and (wors side) leg * EQ-5D-3L

Computer Tomography RADIATION

One additional CT scan is performed for some patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal degenerative deseases from the St Mateenskliniek

You may qualify if:

• Adults ≥ 18 years old
• Diagnosed with the following lumbar spine disorders: foraminal nerve root compression, isthmic spondylolisthesis, and short-segment (1-2 levels) deformity.
• Undergone primary surgery of ALIF or XLIF using titanium cages filled with standalone Fibergraft and with the following criteria fulfilled (ie, the index surgery):
• ALIF (up to 2 levels) as either standalone (ie, no posterior procedure) or as an anterior first procedure with posterior procedure as a second procedure.
• XLIF (up to 2 levels) as an anterior first procedure with posterior procedure as a second procedure.
• Consenting to have CT scans taken to allow assessment of fusion status at 12-24 months post index surgery
• This criterion is applicable to patients who have not undergone revision surgery.
• For patients who have undergone revision surgery due to any reason other than nonunion, which typically occurs within 1 year of the index surgery, this criterion is only applicable if it is possible to obtain the CT scan within 12-24 months of the index surgery. If no CT scan can be taken during this window, the patient does not need to undergo the CT scan; in such cases, the CT scan that has been taken as part of the standard of care before the revision surgery will be retrospectively retrieved to assess the fusion status at the time of the revision surgery.
• This criterion is not applicable to patients who underwent revision surgery due to nonunion, which typically occurs 1 year after the index surgery; these patients do not need to undergo the CT scan. In such cases, the CT scan that has been taken as part of the standard of care before the revision surgery will also be retrospectively retrieved to assess and grade the fusion status at the time of the revision surgery.
• Ability to provide informed consent according to the IRB/EC defined and approved procedures

You may not qualify if:

• Revision surgery
• Standalone XLIF
• Posterior lumbar interbody fusion
• Diagnosis of fractures, malignancies, ankylosing spondylitis, or acute cauda equina syndrome
• Diagnosis of Parkinson's disease
• Body mass index \> 35kg/m2

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (1)

St Mateenskliniek

Ubbergen, 6574, Netherlands

Location

MeSH Terms

Conditions

Spinal Diseases; Spondylolisthesis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Marco Minoia

CONTACT

+41 (0)79 612 09 67; marco.minoia@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)