Arthroplasty ComplicationsNCT05292157
Validation and Feasibility in Clinical Practice and Concordance of an Automated System Coupling an RGB-D Camera and a Software Based on Artificial Intelligence for the Measurement of Shoulder Range of Motion for Patients Operated on a Total Reversed Shoulder Prosthesis.
An observational study of Arthroplasty Complications, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The functional evaluation of the shoulder, which is the most mobile joint in the human body, is a complex clinical examination to perform. The mobility of the shoulder is based on a three-dimensional mobility cone, which is difficult to represent and measure. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 1 Dec 2022
- Phase
- Observational
- 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 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received a reverse total shoulder arthroplasty with more than 2 years of follow-up.
Who may be able to join
- Male or female, age ≥ 18 years old.
- Patient having undergone a total reversed shoulder prosthesis in the department of Orthopedic Surgery of the CHU of Nice - Pasteur Hospital with at least two years of follow-up.
Who cannot join
- patient Not take in charge in the CHU of Nice
- Patient without 2 years of follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Feasibility in Clinical Practice and Concordance of an Automated System Coupling an RGB-D Camera and the ShoulderROM, an Artificial Intelligence -Based Software, for the Measurement of Shoulder Range of Motion for Patients Operated on a Total Reversed Shoulder Prosthesis.
The functional evaluation of the shoulder, which is the most mobile joint in the human body, is a complex clinical examination to perform. The mobility of the shoulder is based on a three-dimensional mobility cone, which is difficult to represent and measure. However, an accurate and reliable measurement of the shoulder's articular amplitude is fundamental for its functional evaluation. Indeed, these measurements contribute to determine the global management strategy of the patient and the follow-up of its evolution.
The conventional method of measuring shoulder joint amplitudes involves the use of a goniometer. Nevertheless, visual estimation is the most used in consultation but is limited by its very examiner-dependent character.
Read more
Technological advances have allowed the development and deployment of additional tools in the clinical setting, with the goal of simplifying, reducing measurement bias, and standardizing joint range of motion (ROM) measurement techniques.
Our team has recently published a study to validate the use of a joint ROM measurement system, coupling a RGB-D (Red Green Blue - Depth) sensor and an artificial intelligence (AI) algorithm, on volunteer subjects with no shoulder history. The RGB-D camera is a technological tool in high development and low cost. It consists of two sensors, an infrared projector and an RGB module. The camera simultaneously provides a two-dimensional (2D) image and its environment by creating a color flow using infrared technology combined with a depth map characterizing the distance of objects seen in the image. The AI algorithm then automatically detects a 2D skeleton that identifies the main joints of the upper limb (shoulder, elbow, wrist) and the trunk axis. Then, the angle of interest is measured and each mobility is automatically measured in 3D by the algorithm.
The main objective of the study is to validate and demonstrate the feasibility in clinical practice and the concordance of an automated RGB-D + AI system for the measurement of shoulder joint ROMs of patients having undergone reverse total shoulder replacement surgery. These measurements will be compared with the visual method and the goniometer, that are measurements made in normal care routine. The ROM measures obtained by means of the RGB-D + AI system will be compared to those obtained in clinical practice during the annual follow-up visit in normal care routine. The main evaluation criterion is the measurement of joint amplitude measured in degrees [°]. The ROMs that will be measured are those normally assessed in clinical practice: abduction-adduction, flexion-extension and external-internal rotation elbow to body or at 90°.
This study aims also at observing and comparing the postoperative joint ROM measurements estimated in the preoperative planning phase by the Blue-Print software with the actual postoperative ROM measured with the RGB-D + AI system.
The study is observational. The processing of the collected data does not foresee any intervention on the patient or modification of the surgeon's choice concerning the management of the patient. It is indeed a RNIPH (Recherche non impliquant la personne humaine).
- Conditions
- Arthroplasty Complications
- Being tested
- shoulder arthroplasty
- Keywords
- shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder arthroplastyProcedure or surgery
range of motion (in degrees) measured in annual postoperative follow-up
| Study group | Role | What they receive |
|---|---|---|
| Reverse total shoulder arthroplasty | Patients who have received a reverse total shoulder arthroplasty with more than 2 years of follow-up in a temporal frame going from 2016 to 2022. Receives: Procedure: shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion (in degrees) measured in annual postoperative follow-up consultation by visual measurement, goniometer and RGB-D + AI system
'The main evaluation criterion is the measurement of joint amplitude measured in degrees [°].
The ranges that will be measured are those normally assessed in clinical practice: abduction-adduction, flexion-extension and external-internal rotation elbow close to body or at 90°.
Measured: 2016-2022
Secondary outcomes (1)
range of motion (in degrees) estimated in preoperative planning with the BluePrint software
'Joint range of postoperative joint range of motion measurements estimated in the preoperative planning phase by the Blue-Print software is compared with the actual postoperative range of motion observed with the system system RGB-D+IA
Measured: 2016-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Jan 2022
- Primary completion1 May 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292157
- Sponsor's protocol ID
- 22Chirortho01
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Feasibility in Clinical Practice and Concordance of an Automated System Coupling an RGB-D Camera and the ShoulderROM, an Artificial Intelligence -Based Software, for the Measurement of Shoulder Range of Motion for Patients Operated on a Total Reversed Shoulder Prosthesis.
- ClinicalTrials.gov ID
- NCT05292157
- Acronym / sponsor ID
- 22Chirortho01
- Conditions
- Arthroplasty Complications
- Keywords
- shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 23 Mar 2022 (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.
The functional evaluation of the shoulder, which is the most mobile joint in the human body, is a complex clinical examination to perform. The mobility of the shoulder is based on a three-dimensional mobility cone, which is difficult to represent and measure. However, an accurate and reliable measurement of the shoulder's articular amplitude is fundamental for its functional evaluation. Indeed, these measurements contribute to determine the global management strategy of the patient and the follow-up of its evolution.
The conventional method of measuring shoulder joint amplitudes involves the use of a goniometer. Nevertheless, visual estimation is the most used in consultation but is limited by its very examiner-dependent character.
Technological advances have allowed the development and deployment of additional tools in the clinical setting, with the goal of simplifying, reducing measurement bias, and standardizing joint range of motion (ROM) measurement techniques.
Our team has recently published a study to validate the use of a joint ROM measurement system, coupling a RGB-D (Red Green Blue - Depth) sensor and an artificial intelligence (AI) algorithm, on volunteer subjects with no shoulder history. The RGB-D camera is a technological tool in high development and low cost. It consists of two sensors, an infrared projector and an RGB module. The camera simultaneously provides a two-dimensional (2D) image and its environment by creating a color flow using infrared technology combined with a depth map characterizing the distance of objects seen in the image. The AI algorithm then automatically detects a 2D skeleton that identifies the main joints of the upper limb (shoulder, elbow, wrist) and the trunk axis. Then, the angle of interest is measured and each mobility is automatically measured in 3D by the algorithm.
The main objective of the study is to validate and demonstrate the feasibility in clinical practice and the concordance of an automated RGB-D + AI system for the measurement of shoulder joint ROMs of patients having undergone reverse total shoulder replacement surgery. These measurements will be compared with the visual method and the goniometer, that are measurements made in normal care routine. The ROM measures obtained by means of the RGB-D + AI system will be compared to those obtained in clinical practice during the annual follow-up visit in normal care routine. The main evaluation criterion is the measurement of joint amplitude measured in degrees [°]. The ROMs that will be measured are those normally assessed in clinical practice: abduction-adduction, flexion-extension and external-internal rotation elbow to body or at 90°.
This study aims also at observing and comparing the postoperative joint ROM measurements estimated in the preoperative planning phase by the Blue-Print software with the actual postoperative ROM measured with the RGB-D + AI system.
The study is observational. The processing of the collected data does not foresee any intervention on the patient or modification of the surgeon's choice concerning the management of the patient. It is indeed a RNIPH (Recherche non impliquant la personne humaine).
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reverse total shoulder arthroplasty | – | Procedure: shoulder arthroplastyPatients who have received a reverse total shoulder arthroplasty with more than 2 years of follow-up in a temporal frame going from 2016 to 2022. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received a reverse total shoulder arthroplasty with more than 2 years of follow-up.
Key inclusion criteria (2 listed)
- Male or female, age ≥ 18 years old.
- Patient having undergone a total reversed shoulder prosthesis in the department of Orthopedic Surgery of the CHU of Nice - Pasteur Hospital with at least two years of follow-up.
Key exclusion criteria (2 listed)
- patient Not take in charge in the CHU of Nice
- Patient without 2 years of follow-up
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 |
|---|---|---|
| shoulder arthroplastyrange of motion (in degrees) measured in annual postoperative follow-up | Procedure or surgery | Reverse total shoulder arthroplasty |
Primary outcome
range of motion (in degrees) measured in annual postoperative follow-up consultation by visual measurement, goniometer and RGB-D + AI system
Time frame: 2016-2022
'The main evaluation criterion is the measurement of joint amplitude measured in degrees [°]. The ranges that will be measured are those normally assessed in clinical practice: abduction-adduction, flexion-extension and external-internal rotation elbow close to body or at 90°.
1 secondary outcome
range of motion (in degrees) estimated in preoperative planning with the BluePrint software
Time frame: 2016-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion (in degrees) measured in annual postoperative follow-up consultation by visual measurement, goniometer and RGB-D + AI system (time frame: 2016-2022). 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 6 Mar 2025.