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

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.

Conditions

• Segmental Long Bone Defects

Interventions

PROCEDURE

Autogenous RIA bone grafting

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.

PROCEDURE

Allogeneic bone grafting

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).

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• The University of Texas Medical Branch, Galveston

  lead OTHER

Principal Investigators

• Zbigniew Gugala, MD,PhD · University o Texas Medical Branch in Galveston, Texas

• Ronald W Lindsey, MD · University o Texas Medical Branch in Galveston, Texas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-01

Primary Completion

2019-09-30

Completion

2019-12-31

Countries

• United States

Study Locations