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Completed Not applicable Interventional Results available

Comparative Efficacy of the Masquelet Versus Titanium Mesh Cage Techniques for the Treatment of Large Long Bone Defects

ClinicalTrials.gov ID: NCT02015390

Public ClinicalTrials.gov record NCT02015390. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

The Comparative Efficacy of the Masquelet Versus Titanium Mesh Cage Reconstruction Techniques for the Treatment of Large Long Bone Deficiencies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 both of these techniques has been very promising, but to date, there has been no prospective clinical study comparing the two new methods of defect treatment. Identifying an optimal surgical bone defect reconstructive technique would significantly improve the clinical outcomes of patients with these challenging conditions.

Study identification

NCT ID
NCT02015390
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
16 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2013
Primary completion
Sep 29, 2019
Completion
Dec 30, 2019
Last update posted
Jun 27, 2021

2013 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The University of Texas Medical Branch Galveston Texas 77555

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02015390, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 27, 2021 · Synced Sep 1, 2026

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