The Comparative Efficacy of the Masquelet versus Titanium Mesh Cage Reconstruction Techniques for the Treatment of Large Long Bone Deficiencies
Abstract
The study comprises a single center, randomized, two-arm clinical trial conducted at the Department of Orthopaedic Surgery and Rehabilitation, University of Texas Medical Branch, Galveston, TX, with a primary objective to assess and compare the functional outcome of patients with large segmental bone defects reconstructed with the Masquelet technique (MT) versus the titanium mesh cage technique (TMCT). The secondary objectives include the radiographic determination of defect healing, and comparative assessment of cost and resource expenditures between the two techniques. From 11 patients with segmental defects presented to our institution over the last 12-month trial period, 6 met the study eligibility criteria and were successfully enrolled, and they include 3 MT, 3 TMCT. There are total 9 patients who have been enrolled in the study, with 7 actively participating. One patients (study subject 2) has been noncompliant with the postoperative management and developed superficial wound infection which progressed into deep infection/cellulitis and culminated with limb amputation. This SAE has been reported to PIs IRB and DoD, and this subject has been excluded from the study. Another subject (study subject 3) did not show up for surgery after signing informed consent. This subject has also been removed from the study. Both these subjects have been reported in the previous annual report. So far, 7 study subjects (4MT, 3 TMCT) are being followed, and they study course is uneventful. There are 3 additional potentially eligible study patients identified. The trial is ongoing and patients enrollment actively in progress.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2015
- Accession Number
- AD1002374
Entities
People
- Ronald W. Lindsey
- Zbigniew Gugala
Organizations
- University of Texas Medical Branch