Shoulder OsteoarthritisNCT04762667
Individual Preoperative Planning for RSA
A study testing reverse shoulder arthroplasty in people with Shoulder Osteoarthritis and Proximal Humeral Fracture, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Osteoarthritis, Proximal Humeral Fracture, Avascular Necrosis of Humerus
- What is being tested?
- reverse shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- massive glenoid injury. Damage to the deltoid muscle.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
Nikolay A Sukharev, +7 (909)9967654, baizil@inbox.ru
About this study
Official title: Preoperative Planning for Reverse Shoulder Arthroplasty Using Individual Planing Strategy
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.
Read the 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.
- Being tested
- reverse shoulder arthroplasty
- Keywords
- reverse shoulder arthroplasty, patient-specific instrumentation, preoperative planning
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reverse shoulder arthroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: reverse shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSCT after RSA.
postoperative MSCT data will be used for our endpoint in early postoperative period
Measured: up to 24 weeks
Secondary outcomes (2)
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).
Measured: 6 months.
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)
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Sep 2019
- Primary completion31 May 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolay A. Sukharev, Study chair, university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762667
- Sponsor's protocol ID
- 180195
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Planning for Reverse Shoulder Arthroplasty Using Individual Planing Strategy
- ClinicalTrials.gov ID
- NCT04762667
- Acronym / sponsor ID
- 180195
- Keywords
- reverse shoulder arthroplasty, patient-specific instrumentation, preoperative planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients will undergo reverse shoulder arthroplasty with patient-specific instrumentation. | Experimental | Procedure: reverse shoulder arthroplastyThe 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. |
| Patients will undergo conventional reverse shoulder arthroplasty. | Other | Procedure: reverse shoulder arthroplastyThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- massive glenoid injury. Damage to the deltoid muscle.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reverse shoulder arthroplastyIn 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. | Procedure or surgery | Patients will undergo conventional reverse shoulder arthroplasty., Patients will undergo reverse shoulder arthroplasty with patient-specific instrumentation. |
Primary outcome
MSCT after RSA.
Time frame: up to 24 weeks
postoperative MSCT data will be used for our endpoint in early postoperative period
2 secondary outcomes
Functional outcomes are assessed according to the Constant-Murley Score
Time frame: 6 months.
Functional outcomes are assessed according to the University of California, Los Angeles Shoulder Assessment
Time frame: 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolay A. Sukharev study chair
university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reverse shoulder arthroplasty in people with Shoulder Osteoarthritis and Proximal Humeral Fracture, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksey V. Lychagin, Doctor of Science (84955303354, dr.lychagin@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSCT after RSA. (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.