CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Autogenous RIA bone grafting +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02015390
NCT02015390N/ACompleted

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

The University of Texas Medical Branch, Galveston·interventional·Posted Dec 19, 2013·Updated Jun 28, 2021

In Brief

A clinical study evaluating Autogenous RIA bone grafting and Allogeneic bone grafting for Segmental Long Bone Defects. Completed, enrolled 16 participants across 1 site.

Detailed 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 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 19, 2013
Enrollment StartOct 1, 2013
Primary CompletionSep 30, 2019
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 12.5 years ago

Interventions

Autogenous RIA bone graftingprocedure

After aseptic defect and adequate soft tissue coverage have been achieved, the defect reconstruction technique will include autogenous bone grafting harvesting using Reamer-Irrigator-Aspirator (RIA) and packing it within the defect.

Allogeneic bone graftingprocedure

After aseptic defect and adequate soft tissue coverage have been achieved, the defect reconstruction technique will include defect packing with allogeneic bone graft croutons combined with demineralized bone matrix (DBM).