Last reviewed · How we verify
NCT03893110
Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors
NA trial testing surgical stabilization of the spine due to primary and secondary spinal tumors in Spinal Tumor. Withdrawn.
31 January 2022
Quick facts
| Lead sponsor | Balgrist University Hospital |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 27 June 2018 |
| Primary completion | 31 January 2022 |
| Estimated completion | 31 March 2022 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- surgical stabilization of the spine due to primary and secondary spinal tumors
Conditions studied
- Spinal Tumor — all drugs for Spinal Tumor →
Sponsor
Balgrist University Hospital
Who can join
Adults 18 to 99, any sex, with Spinal Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Radiation therapy is a cornerstone in the treatment of spinal neoplasms as radical resections are often limited anatomically. Frequently, a surgical stabilization with implants is required. However, metallic implants not only make the CT-based planning of a subsequent radiation therapy more difficult, but might also have an uncontrolled dose modulating effect in adjuvant radiotherapy. At the spine, radiation is limited by the effective dose posed to the relatively radiosensitive spinal cord. While metallic implants might result in an inhomogeneous and uncontrollable dose distribution due to the interface effect, the use of new radiolucent implants consisting of carbon/polyether ether ketone (PEEK) might allow a more homogeneous and predictable dose distribution. This study aims to evaluate the potential benefits of the use of carbon/PEEK pedicle screws during adjuvant radiation therapy and follow-up imaging of spinal tumors. 60 patients will randomized 1:1 into either treatment arm (Pedicle System Carbon/PEEK vs. Pedicle System Titanium). The feasibility of planning the radiation therapy will be evaluated. The postoperatively administered total radiation dose is documented. The radiological visualization of the area of interest will be evaluated The surgical outcome is evaluated by fusion rate, implant integrity and anchorage. Patients will be followed up for 12 months according to local standards.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03893110
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Spinal Tumor
Currently open trials in the same condition.
- NCT06120426 — En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor · recruiting
- NCT06613295 — Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases · NA · recruiting
- NCT03839914 — Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients · NA · recruiting
- NCT03956537 — PMCF Neo Pedicle Screw and Cage Systems · active not recruiting
- NCT03398915 — The European Robotic Spinal Instrumentation (EUROSPIN) Study · active not recruiting
Other Balgrist University Hospital trials
Trials by the same sponsor.
- NCT06813859 — Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device · not yet recruiting
- NCT06668116 — The Impact of Local Anesthetic Dilution on Possible Blinding for Nerve Blocks · NA · completed
- NCT06552195 — Augmented Reality in Learning Anatomy: The TEACHANATOMY Randomized Cross-over Trial · NA · not yet recruiting
- NCT06443879 — Loss and Return of Sensation After Axillary Brachial Plexus Nerve Block - Distally or Proximally · completed
- NCT06036849 — Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03893110 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Balgrist University Hospital
- Last refreshed: 30 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03893110.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing