Spots Global Cancer Trial Database for Mandibular Reconstruction Preplanning (ViPMR)

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Trial Identification

Brief Title: Mandibular Reconstruction Preplanning (ViPMR)

Official Title: Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial

Study ID: NCT05429099

Conditions

Oral Cavity Cancer

Oral Cancer

Interventions

Virtual Surgical Planning (VSP)

Free-Hand Surgery

Study Description

Brief Summary: Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.

Detailed Description: