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NCT02015390 · ClinicalTrials.gov registry record · NA
Comparative Efficacy of the Masquelet Versus Titanium Mesh Cage Techniques for the Treatment of Large Long Bone Defects
A NA study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT02015390 is a NA study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 16 participants.
The verdict
NCT02015390, a NA study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
The United States Department of Defense (DoD) is funding exciting new research at the University of Texas Medical Branch (UTMB) Department of Orthopaedic Surgery and Rehabilitation that can be a major improvement in the treatment of extremity trauma involving segmental bone loss. These devastating injuries occur frequently in both civilians and the military. They typically result from motor vehicle accidents, high-energy fractures, gunshot injuries, and blast injuries, but also from the surgical removal of a bone segment because of infection or tumor. Despite many modern medical advances in this area, bone healing that can adequately replace bone loss and restore pre-injury limb function is extremely difficult to achieve. Existing standard treatment procedures are exceedingly complicated, require highly specialized equipment and clinical skills, and usually require many surgical procedures over many months or years. Despite these effort and costs, major complications usually occur with all the standard treatment options, the patient's ability to return to an acceptable functional status is typically low, and, therefore, many of these patients have their limbs amputated. The UTMB Department of Orthopaedic Surgery and Rehabilitation will conduct a DoD-funded clinical trial to determine and compare the advantages of two new and innovative surgical bone defect treatment techniques that can be significantly more effective for wounded warriors or civilian patients and with these conditions. One treatment method, called "the Masquelet Technique", involves two-stage surgery: the first one to create a biomembrane around the defect by applying a cement spacer, and then the second one for cement spacer removal and defect bone grafting. The other method, developed by UTMB physicians, is "the Cage Technique" and it comprises one-stage surgery in which a special hollow, fenestrated, titanium cage filled with bone graft is implanted in the defect. Initial clinical experience with
Interventions
- PROCEDURE Autogenous RIA bone grafting
- PROCEDURE Allogeneic bone grafting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02015390
The ClinicalTrials.gov registry entry for NCT02015390 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Autogenous RIA bone grafting is the first listed.
NCT02015390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02015390 about?
NCT02015390 is a clinical study titled "Comparative Efficacy of the Masquelet Versus Titanium Mesh Cage Techniques for the Treatment of Large Long Bone Defects". The United States Department of Defense (DoD) is funding exciting new research at the University of Texas Medical Branch (UTMB) Department of Orthopaedic Surgery and Rehabilitation that can be a major improvement in the treatment of extremity trauma involving segmental bone loss. These devastating i...
What is the current status of trial NCT02015390?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2013-10-01. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT02015390?
The interventions under investigation include: Autogenous RIA bone grafting (PROCEDURE), Allogeneic bone grafting (PROCEDURE).
Who is sponsoring clinical trial NCT02015390?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
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