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Individual Preoperative Planning for RSA

Primary Purpose

Shoulder Osteoarthritis, Proximal Humeral Fracture, Avascular Necrosis of Humerus

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
reverse shoulder arthroplasty
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Osteoarthritis focused on measuring reverse shoulder arthroplasty, patient-specific instrumentation, preoperative planning

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

massive glenoid injury. Damage to the deltoid muscle.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

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

Patients will undergo conventional reverse shoulder arthroplasty.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional outcomes are assessed according to the Constant-Murley Score
assessment of the general condition, functional status of a normal or damaged shoulder joint. It consists of a section for both objective and subjective assessment, subdivided into sub-items including pain (maximum 15 points), daily activity (maximum 20 points), range of motion (maximum 40 points) and limb strength (maximum 25 points). The higher the indicator, the correspondingly better the function (minimum 0, maximum 100).
Functional outcomes are assessed according to the University of California, Los Angeles Shoulder Assessment
The questionnaire includes scores for pain assessment (from 1 to 10) and function (from 1 to 10). Additionally, active anterior flexion is scored from 0 to 5 points, active flexion strength is 0-5 points, patient satisfaction is 0-5 points. Strength and range of motion are assessed by a doctor or physiotherapist, the rest of the parameters are assessed by the patient himself. The highest score can reach 35 points, the result above 27 points is assessed as good / excellent (satisfactory), below 27 - poor (unsatisfactory)

Full Information

First Posted
January 28, 2021
Last Updated
February 19, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04762667
Brief Title
Individual Preoperative Planning for RSA
Official Title
Preoperative Planning for Reverse Shoulder Arthroplasty Using Individual Planing Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Background: 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 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. Purpose: show the effectiveness of accurate preoperative planning and prove it using patient-specific instrumentation. Methods: Patients aged 18 and older, male and female, are participating in our study. The established diagnosis: multifragmental fracture of the humerus head; aseptic necrosis of the humerus head; complete tears of the rotator cuff; arthrosis of the shoulder joint; rheumatoid arthritis of the shoulder joint. The study included 65 shoulders with shoulder joint pathology. The main group included 15 patients. This group of patients will undergo reverse shoulder arthroplasty with patient-specific instrumentation. Second group of patients will undergo conventional reverse shoulder arthroplasty. In investigators work, all patients are performs MSCT of the shoulder joint, clinical assessment of the shoulder joint and assessment of neurological status. The planning of the position of the endoprosthesis components in the main group of patients was carried out in several stages. The first stage: the position of the guide wire was calculated, taking into account the individual anatomy of the patient. The second step is to measure the angle of the pilot spoke in the axial projection. In the third stage, the planting depth is estimated. It is necessary to strive for complete adherence of the component, but at the same time, one should not forget about the preservation of the glenoid bone mass. At the fourth stage, the position of the fixing screws was calculated. Given the angle of inclination of the screws of 30 degrees, it is necessary to design the position of the screws on the 3D model so that they are as deep as possible in the bone mass. Due to this, we will obtain a reliable fixation for the glenoid base. Then we measure the length of the bone canals for the screws. The fifth stage is to calculate the direction of resection of the humeral head. For this, in a direct projection in the area of the anatomical neck, an angle of 135 degrees is built relative to the central axis of the bone. Construction of a 3D model is carried out using the obtained data first group patients. 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 for first group patients. 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. Functional outcomes are assessed according to the Constant-Murley Score, the University of California, Los Angeles Shoulder Assessment, and (Shoulder assessment form american shoulder and elbow surgeons, (ASES) Shoulder Outcome Score). Functional results are seen after 1, 6 and 12 months. Planned results: in this study, we hope to prove the effectiveness of preoperative planning. The investigators expect that the precise positioning of the components using patient-specific instrumentation will increase the range of motion in the shoulder joint, reduce the complication rate, and also improve the quality of life of patients after reverse shoulder arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Osteoarthritis, Proximal Humeral Fracture, Avascular Necrosis of Humerus
Keywords
reverse shoulder arthroplasty, patient-specific instrumentation, preoperative planning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients will undergo reverse shoulder arthroplasty with patient-specific instrumentation.
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients will undergo conventional reverse shoulder arthroplasty.
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
reverse shoulder arthroplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
MSCT after RSA.
Description
postoperative MSCT data will be used for our endpoint in early postoperative period
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Functional outcomes are assessed according to the Constant-Murley Score
Description
assessment of the general condition, functional status of a normal or damaged shoulder joint. It consists of a section for both objective and subjective assessment, subdivided into sub-items including pain (maximum 15 points), daily activity (maximum 20 points), range of motion (maximum 40 points) and limb strength (maximum 25 points). The higher the indicator, the correspondingly better the function (minimum 0, maximum 100).
Time Frame
6 months.
Title
Functional outcomes are assessed according to the University of California, Los Angeles Shoulder Assessment
Description
The questionnaire includes scores for pain assessment (from 1 to 10) and function (from 1 to 10). Additionally, active anterior flexion is scored from 0 to 5 points, active flexion strength is 0-5 points, patient satisfaction is 0-5 points. Strength and range of motion are assessed by a doctor or physiotherapist, the rest of the parameters are assessed by the patient himself. The highest score can reach 35 points, the result above 27 points is assessed as good / excellent (satisfactory), below 27 - poor (unsatisfactory)
Time Frame
6 months.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: massive glenoid injury. Damage to the deltoid muscle.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksey V. Lychagin, Doctor of Science
Phone
84955303354
Email
dr.lychagin@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Nikolay A. Sukharev
Phone
89099967654
Email
baizil@inbox.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolay A. Sukharev
Organizational Affiliation
university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. Moscow, Russia
Official's Role
Study Chair
Facility Information:
Facility Name
I.M. Sechenov First Moscow State Medical University (Sechenov University)
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolay A Sukharev
Phone
+7 (909)9967654
Email
baizil@inbox.ru

12. IPD Sharing Statement

Plan to Share IPD
No

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Individual Preoperative Planning for RSA

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