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 24 patients with segmental defects presented to our institution throughout the trial period, 16 met the study eligibility criteria and were successfully enrolled, and they include 9 MT, 7 TMCT. Within the last 12-month study period, 8 patients were enrolled, 2 completed the study, 1 was withdrawn, and 11 are actively participating. Two patients (study subject #4 and subject #14) experienced adverse events AEs, of which one was related with the study and the subject was excluded from continuation in the trial as perstudy protocol. Both AEs have been reported to PIs IRB and DoD. So far, 11 study subjects (6 MT, 5 TMCT) are being actively followed, and their study courses are uneventful. There are 3 additional potentially eligible study patients identified. The trial is ongoing and patients enrollment is in progress.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2016
- Accession Number
- AD1031778
Entities
People
- Ronald W. Lindsey
- Zbigniew Gugala
Organizations
- University of Texas Medical Branch