Rate of Bone Union After Surgery With Stand-alone Fibergraft

N/ANot Yet RecruitingNCT07199075

AO Innovation Translation Center80 enrolled

Overview

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

Lumbar interbody fusion is an established procedure for patients with lumbar degenerative conditions and spondylolisthesis, with symptoms of pain, radiculopathy, and/or myelopathy. Completion of fusion, ie, union, of an intended motion segment remains a desirable endpoint of spinal fusion, supported by the observations that pseudoarthrosis, ie, nonunion, following spinal fusion is correlated with poorer patient outcomes. Iliac crest bone autograft is considered the gold standard for spinal fusion with excellent fusion rates and clinical outcomes. However, its clinical use has been restricted due to limited availability of harvestable bone, donor-site morbidity, increased surgical time, and the need for additional surgical staff and associated costs. As a result, there has been great interest in the search for bone graft substitutes to replace or reduce the amount of autograft, which will lower the risks associated with the harvesting procedure while still providing a favorable environment for a solid fusion. A wide range of synthetic bone grafts have been explored, including ceramics, bioactive glasses, and polymer-based compounds. Although bioactive glasses have been used in spinal fusion for three decades, literature on them is dispersed over the wide array of bioactive glasses investigated and numerous small clinical studies. There is marked variability in these studies in terms of the patient population, indications, procedures performed, single- vs multi-level procedures, types of bioactive glasses, use of autografts, duration of follow-up (FU), and methods to determine fusion status. It is therefore difficult to draw conclusions on the optimal bioactive glass for a particular application. Nonetheless, the current literature suggests that bioactive glasses may be effective as bone graft extenders when combined with autograft to promote spinal fusion, yielding at least noninferior fusion rates when compared with autograft alone. There is limited data regarding the effectiveness of bone glasses as standalone bone graft substitutes or in interbody fusion procedures. This single-center study to be conducted at the St. Maartenskliniek, the Netherlands, aims to address this knowledge gap. Since 2023, the hospital has consistently used Fibergraft Bioactive Glass (BG) Putty, a product from the FIBERGRAFTTM Bioactive Bone Graft Substitute family (Johnson \& Johnson MedTech), as standalone cage fillers for anterior lumbar interbody fusion (ALIF) and extreme lateral interbody fusion (XLIF). This provides an opportunity for a case series to determine the fusion rate for bioactive glass as a standalone bone graft substitute in lumbar interbody fusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: 12months to 24th months after index surgery

Secondary Outcomes

Oswestry Disability Index (ODI)

The level of disability will be measured using the ODI . The ODI is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, with 5 representing the greatest disability. The index is calculated by dividing the sum of the scores by the total possible score, which is then multiplied by 100 and expressed as a percentage. The preoperative ODI will be retrospectively collected via medical records, and patients will fill out the ODI at the 12-24 months visit.

Time frame: Before the index surgery and 12-24months post index surgery

General back pain and (worse side) leg pain

General back pain and (worse side) leg pain will be measured by the patients on an NRS of 0 to 10, with 0 representing no pain and 10 the worst imaginable pain. Preoperative pain NRS will be retrospectively collected via medical records, and patients will fill out pain NRS at the 12-24 months visit.

Time frame: Before the index surgery and 12-24 months after the index surgery

The EuroQoL-5 Dimension

The EQ-5D is a generic measure of self-reported health developed by the EuroQol Group. It measures five dimensions for describing health states: mobility, usual activities, self-care, pain and discomfort, and anxiety and depression. The questionnaire is comprised of two parts. The first part is the EQ-5D descriptive system, in which individuals are asked to indicate the level of problem they experience on each of the five dimensions. The second part is the EQ Visual Analogue Scale, which captures the individual's overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). For this study, the EQ-5D-3L (3 levels) version will be used. Preoperative EQ-5D-3L will be retrospectively collected via medical records, and patients will fill out EQ-5D-3L at the 12-24 months visit.

Time frame: Before the index surgery and 12-24months after the index surgery

Patient's overall satisfaction

Patients' overall satisfaction with the treatment will be measured on a 7-point Likert scale at the 12-24 months visit. * Extremely satisfied * Very satisfied * Somewhat satisfied * Mixed (approximately equal satisfaction and dissatisfaction) * Somewhat dissatisfied * Very dissatisfied * Extremely dissatisfied

Time frame: 12months to 24th months after the index surgery

Complications

The following AEs/complications are of particular interest to the study. The dates when they occur and their treatments (reoperation, medical treatment, or no interventions) will be documented: * Dural tear (if the patient has undergone posterior procedure) * Persistent radiculopathy * Sensory deficit * Motor deficit * Persistent back pain * Cauda syndrome (if the patient has undergone posterior procedure) * Retrograde ejaculation (for male patients) * Vascular injury (if the patient has undergone anterior procedure) * Hardware failure * Pseudoarthrosis * Persistent wound leakage * Surgical wound infection (superficial) * Surgical wound infection (deep) * Deep vein thrombosis * Pulmonary embolism * Pneumonia * Urinary tract infection * Other, specify In addition to postoperative complications, several radiographic findings and the date of detection on images will also be recorded: • Cage subsidence * If yes, levels of cage subsidence (multiple answers possible): T12-L1 to L5-S1 * For

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

Reoperations

Any reoperation of the index levels and the adjacent levels, such as revision, removal of implants, and supplemental fixation, will be documented

Time frame: From after the index surgery until the 12months to 24months visit after the index surgery

Rate of Bone Union After Surgery With Stand-alone Fibergraft

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts