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, The University of Texas Medical Branch at Galveston, Texas, with a primary objective to assess and compare the functional outcomes of patients with large segmental bone defects reconstructed with the Masquelet technique (MT) versus the titanium mesh cage technique (CT). 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 entire trial period, 16 met the study eligibility criteria and were successfully enrolled, and they included 9 MT and 7 CT patients. Within the study period encompassing the last annual report, 7 patients completed the study by reaching the study endpoint, whereas 1 patients followup was interrupt due to incarceration which precluded continuation in the study, and 1 enrolled patient (CT) received pre-reconstructive defect treatment (infection eradication) but did not meet clinical criteria for the cage reconstructive surgery. Thus, collectively throughout the entire study period, from the total 16 enrolled patients, 11 study subjects (8 MT, 3 CT) completed all the trial followup visits; 1 patient (MT)had incomplete followup, 3 patients (all CT) developed adverse events (recurrence of defect infection) and were removed from the study as reported previously, and 1 patient (CT) was removed due to noncompliance with the study protocol. 1 patient from the Masquelet arm developed unrelated AE and remained in the study. The trial enrollment has been closed, and the participation of all enrolled subjects has ended. The study will be formally closed with IRB before its annual renewal expiration on Jan 14, 2021.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 01, 2019
- Accession Number
- AD1106308
Entities
People
- Zbigniew Gugala
Organizations
- University of Texas Medical Branch