Archives of orthopaedic and trauma surgery
First-in-human prospective pilot study of a bipolar dual-center total wrist arthroplasty: early mechanical stability and clinical outcomes
By Israeli R, Gorelick L, Gannot G and 1 others.
Abstract
Purpose
Total wrist arthroplasty (TWA) is limited by implant loosening, instability, and non-physiological load transfer, partly because most contemporary implants rely on a single center of rotation and do not preserve native wrist kinematics. This first-in-human pilot study evaluated the feasibility, early mechanical stability, and clinical outcomes of a novel bipolar dual-center TWA system designed to preserve radiocarpal and midcarpal motion.
Methods
This prospective single-center pilot case series included five consecutive patients with end-stage wrist arthritis treated with a bipolar dual-center TWA implant using cement fixation, as per the device's intended use. The outcome measures included pain assessed using the pain subscale of the Patient-Rated Wrist Evaluation (PRWE) questionnaire (normalized to a 0-10 scale), total PRWE score, DASH score, range of motion, grip strength, radiographic implant stability, complications, and reoperation. Clinical outcomes were assessed at the most recent follow-up visit.