Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial.

BACKGROUND: Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The treatment is associated with costs and the recovery may take up to 1 year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket TMC prosthesis to trapeziectomy with ligament reconstruction. METHODS: A randomized, blinded, parallel-group superiority clinical trial comparing trapeziectomy with abductor pollicis longus (APL) arthroplasty and prosthetic replacement with Maïa® prosthesis. Patients, 18 years old and older, with a clinical diagnosis of unilateral or bilateral TMC OA who fulfill the trial's eligibility criteria will be invited to participate. The diagnosis will be made by experienced hand surgeons based on symptoms, clinical history, physical examination, and complementary imaging tests. A total of 106 patients who provide informed consent will be randomly assigned to treatment with APL arthroplasty and prosthetic replacement with Maïa® prosthesis. The participants will complete different questionnaires including EuroQuol 5D-5L (EQ-5D-5L), the Quick DASH, and the Patient Rated Wrist Evaluation (PRWE) at baseline, at 6 weeks, and 3, 6, 12, 24, 36, 48, and 60 months after surgical treatment. The participants will undergo physical examination, range of motion assessment, and strength measure every appointment. The trial's primary outcome variable is the change in the visual analog scale (VAS) from baseline to 12 months. A long-term follow-up analysis will be performed every year for 5 years to assess chronic changes and prosthesis survival rate. The costs will be calculated from the provider's and society perspective using direct and indirect medical costs. DISCUSSION: This is the first randomized study that investigates the effectiveness and cost-utility of trapeziectomy and ligament reconstruction arthroplasty and Maïa prosthesis. We expect the findings from this trial to lead to new insights into the surgical approach to TMC OA. TRIAL REGISTRATION: ClinicalTrials.gov NCT04562753. Registered on June 15, 2020.

Distal humerus shear-fractures: "Built-on" surgical technique.

When treating a distal humeral shear fracture, comminution of the lateral column may preclude the reconstruction of the lateral articular fragments. In this article a new strategy for the management lateral column comminuted shear-fractures (LCCSF) is presented, called the "built-on" surgical technique. Three goals are obtained by this technique: (1) Restoration of the lateral column bone stock; (2) Provision of a solid scaffold for the repair of the lateral ulnar collateral ligament (LUCL); and (3) Provision of a sable platform for the reconstruction and fixation of the articular fragments. We will obtain these goals through the following surgical steps: 1/ Reconstruction of the lateral trochlea. 2/ Reconstruction of the lateral column 3/ Fixation of the Capitellum 4/ Reconstruction of the LUCL.