Individual Preoperative Planning for RSA

NCT04762667 | Unknown DMC

• 1 other identifier: 180195
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

reverse shoulder arthroplasty; patient-specific instrumentation; preoperative planning

Outcome Measures

Primary Outcomes (1)

• MSCT after RSA.

  postoperative MSCT data will be used for our endpoint in early postoperative period

  up to 24 weeks

Secondary Outcomes (2)

• Functional outcomes are assessed according to the Constant-Murley Score

  6 months.

• Functional outcomes are assessed according to the University of California, Los Angeles Shoulder Assessment

  6 months.

Study Arms (2)

Patients will undergo reverse shoulder arthroplasty with patient-specific instrumentation.

EXPERIMENTAL

The patients underwent preoperative planning. A 3D model was made based on CT. The optimal position of the components of the endoprosthesis has been calculated. patient-specific instrumentation were created for each scapula and humerus using 3D modeling software. Individual guides use during operation for exact position of the components of the endoprosthesis.

Procedure: reverse shoulder arthroplasty

Patients will undergo conventional reverse shoulder arthroplasty.

OTHER

This group of patients was examined according to the standard method, Rg and CT of the shoulder joint were performed. According to the study, the sizes of the endoprosthesis were selected. Installation of the components of the endoprosthesis during the operation was carried out using standard (included in the set) guides. Orientation was performed according to the anatomical landmarks of the glenoid and the neck of the humerus, without taking into account the individual characteristics of the bones.

Procedure: reverse shoulder arthroplasty

Interventions

reverse shoulder arthroplasty PROCEDURE

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.

Patients will undergo conventional reverse shoulder arthroplasty.; Patients will undergo reverse shoulder arthroplasty with patient-specific instrumentation.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis: multifragmental fracture of the humerus head; aseptic necrosis of the humerus head; arthrosis of the shoulder joint.
• Must be have pain and limitation of movement of the shoulder joint.

You may not qualify if:

• massive glenoid injury. Damage to the deltoid muscle.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Nikolay A. Sukharev

  university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. Moscow, Russia

  STUDY CHAIR

Central Study Contacts

Aleksey V. Lychagin, Doctor of Science

CONTACT

84955303354; dr.lychagin@mail.ru

Nikolay A. Sukharev

CONTACT

89099967654; baizil@inbox.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 21, 2021
• Study Start: September 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: August 31, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)