Clinical trial · Observational
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate
Expandable Pedicle Screws Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients With Osteoporosis or Poor Bone Quality
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteoporosis | — | UNRESOLVED | — |
| Poor Bone Quality | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OsseoScrew Spinal Fixation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- OsseoScrew
- description
- Test Product: OsseoScrew Spinal Fixation System
- interventionNames
- Device: OsseoScrew Spinal Fixation System
- label
- Fenestrated Screw
- description
- Control Product: Any commercially available fenestrated screw system augmented with PMMA
Primary outcomes (2)
- measure
- Safety Endpoint: Rate of device-related or PMMA-related complications
- timeFrame
- 24 months
- description
- The proportion of patients who were free from device-related or PMMA-related complications leading to revision, supplemental fixation, non-elective removal, or reoperation throughout the study. Complications included, but were not limited to device or PMMA fracture, device or PMMA-related loosening, device or PMMA-related device disassembly, device migration or PMMA extravasation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years of age 2. Spinal instability or deformity requiring fusion with instrumentation 3. Osteopenia defined as (T-Score of less than -1.0) 4. No response to nonoperative treatment modalities preceding enrollment. 5. Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study and to return for scheduled follow-up evaluations Exclusion Criteria: 1. Active systemic or local infection 2. A life expectancy less than the study duration 3. Autoimmune disorders 4. Currently an alcohol, solvent, or drug abuser 5. Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements 6. History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)
References
Publications (0)
Data not yet available