Shoulder Osteoarthritisgame-readyNCT04702139
Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty
A study testing shoulder arthroplastis in people with Shoulder Osteoarthritis, run by Clinique Bizet at 1 site in France.
Trial summary
The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Osteoarthritis
- What is being tested?
- shoulder arthroplastis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2021to 30 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-line reverse prosthesis
- Without prosthetic history
- Patient who has given his consent to participate in the observational study after being informed by the surgeon
- Patient living in France and able to answer the questionnaire alone.
- Subject affiliated to a social security scheme or beneficiary of such a scheme
- Lack of participation in another clinical study
Who cannot join
- Minor patient
- Major subject protected by law, under curatorship or tutorship
- Anterior prosthesis
- Infection
- Parkinson's, degenerative neurological disease
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint
- Conditions
- Shoulder Osteoarthritis
- Being tested
- shoulder arthroplastis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder arthroplastisDevice
- Group (Treatment): Placement of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs.
shoulder arthroplastisDevice
- Group (Control): Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days.
| Study group | Role | What they receive |
|---|---|---|
| patient with game-ready splint | Active comparator | Installation of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs. Receives: Device: shoulder arthroplastis |
| patient with standard splint | Placebo comparator | Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days. Receives: Device: shoulder arthroplastis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of postoperative pain following the installation of the Game Ready
Visual Analog Score for pain
Measured: 9 months
Secondary outcomes (5)
risk of stiffness
Physicians Global Assessment to measure risk of stiffness
Measured: up to 9 months
occurrence of hematoma, edema
Physicians Global Assessment to measure the occurrence of hematoma, edema
Measured: up to 9 months
length of hospitalization
Physicians Global Assessment to measure the length of hospitalisation
Measured: up to 24 hours
evolution of mobility
Simple shoulder test, subjective shoulder value, and American Shoulder and Elbow Surgeons Shoulder Score
Measured: up to 9 months
the time limit for returning to a possible professional activity
Physicians Global Assessment to measure quality of life
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start12 Apr 2021
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- philippe VALENTI, DOCTOR, Principal investigator, Clinique Bizet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702139
- Sponsor's protocol ID
- 2020-A02470-39
- Acronym
- game-ready
- Status last verified
- Sep 2023
- First submitted
- 6 Jan 2021
- Last updated
- 14 Nov 2024
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04702139
- Acronym / sponsor ID
- game-ready / 2020-A02470-39
- Conditions
- Shoulder Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Jan 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.
The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with game-ready splint | Active comparator | Device: shoulder arthroplastisInstallation of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs. |
| patient with standard splint | Placebo comparator | Device: shoulder arthroplastisPlacement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First-line reverse prosthesis
- Without prosthetic history
- Patient who has given his consent to participate in the observational study after being informed by the surgeon
- Patient living in France and able to answer the questionnaire alone.
- Subject affiliated to a social security scheme or beneficiary of such a scheme
Key exclusion criteria (6 listed)
- Minor patient
- Major subject protected by law, under curatorship or tutorship
- Anterior prosthesis
- Infection
- Parkinson's, degenerative neurological disease
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 arthroplastis- Group (Treatment): Placement of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs. | Device | patient with game-ready splint |
| shoulder arthroplastis- Group (Control): Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days. | Device | patient with standard splint |
Primary outcome
the level of postoperative pain following the installation of the Game Ready
Time frame: 9 months
Visual Analog Score for pain
5 secondary outcomes
risk of stiffness
Time frame: up to 9 months
occurrence of hematoma, edema
Time frame: up to 9 months
length of hospitalization
Time frame: up to 24 hours
evolution of mobility
Time frame: up to 9 months
the time limit for returning to a possible professional activity
Time frame: up to 3 months
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 14 Nov 2024.
- 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.
philippe VALENTI, DOCTOR principal investigator
Clinique Bizet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shoulder arthroplastis in people with Shoulder Osteoarthritis, run by Clinique Bizet 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 6 inclusion and 6 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 14 Nov 2024. 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. Some participants in this study may receive a placebo. 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?
the level of postoperative pain following the installation of the Game Ready (time frame: 9 months). 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 14 Nov 2024.