Individual Preoperative Planning for RSA

NCT04762667 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-02-21

No results posted yet for this study

Summary

Degenerative diseases and traumatic injuries of the shoulder joint, lead to dysfunction of the arm. Arthroplasty has recently become an increasingly popular operation for severe damage to the shoulder joint. In clinical practice, the most effective operation today is the reverse shoulder arthroplasty (RSA), after the installation of which the pain syndrome disappears in patients and a satisfactory range of motion in the shoulder joint resumes. With the increasing use of reverse shoulder arthroplasty and its expanding indications, surgeons today are facing tougher reconstructive challenges while still providing the patient with a good clinical outcome. The damaged joint presents a problem for the surgeon during component positioning. Implants must place the in a location and orientation that optimizes range of motion and stability while minimizing impingement. In order to address this, surgeons can look to the use of 3D imaging in order to better understand each patient's pathology.

All patients are performed computed tomography scans (CT) of the shoulder joint. Then, were reconstructed 3D model. To determine the position of the components is mounted a scapular plane was created based on 3 points on the 3D reconstructed scapula: center of the glenoid fossa, most medial point on the spinal border of the scapula, and most distal point on the inferior angle of the scapula. The investigators use a scapular plane for to determine the optimal angles of inclination of the reverse baseplate. Then the position and direction of the pilot pin is determined. The position of the fixing screws and their length are also calculated. A resection line is planned for the humerus.

Preoperative virtual templating can be used to translate the preoperative plan into the operating suite in the form of patient specific instrumentation (PSI) and intraoperative navigation. PSI to reference the local anatomy in order to place the guide pin in the desired location, version, and inclination based on the preoperative plan. After surgery, all patients undergo a CT scan of the shoulder joint. These data are compared with CT scan of patients operated on according to the standard method. The range of motion is also assessed and compared.

Conditions

  • Shoulder Osteoarthritis
  • Proximal Humeral Fracture
  • Avascular Necrosis of Humerus

Interventions

PROCEDURE

reverse shoulder arthroplasty

In our work, all patients are performs MSCT of the shoulder joint. The construction of a 3D model is carried out using the obtained data. Taking into account the individual features of the bone structure of the shoulder joint, images of the pilot wire guides, fixing screws and a resection template for the humerus are created. Holes for fixing spokes for the planned structures are also calculated. Using a 3D printer, models of guides and a resection template are printed. During the reverse shoulder arthropalsty, instead of a standard guide, patient-specific instrumentation are used. In the early postoperative period, all patients are performs MSCT of the shoulder joint. The obtained data are compared with the results of MSCT of the shoulder joints of patients previously operated on using the standard technique.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Nikolay A. Sukharev · university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. Moscow, Russia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-05-31
Completion
2021-08-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04762667 on ClinicalTrials.gov