Labral Tear, GlenoidNCT04278716
Return to Play Checklist
An observational study of Labral Tear, Glenoid, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study will try to develop and determine objective and validated criteria for our athletes to safely return to sports after labral repair. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Labral Tear, Glenoid
- What is being tested?
- Safe return to play checklist
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to Jun 2021
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: All athletes undergoing arthroscopic capsulolabral repair surgery will be eligible for participation
Who may be able to join
- Males and non-pregnant females aged 15 years or older with a capsulolabral tear undergoing arthroscopic capsulolabral repair surgery at the Rothman Institute with one of the investigators
Who cannot join
- Patients with an labral repair
- Patients only undergoing debridements with no repair
- Patients undergoing revision shoulder surgery or those with a history of multiple shoulder surgeries
- Concomitant severe glenohumeral arthritis or adhesive capsulitis
- Patients with a worker's compensation claim
- Patients diagnosed with psychological disorders
- Patients with a history of alcohol or drug abuse -Patients on preoperative narcotic therapy -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor, New Jersey, 08234
About this study
Official title: Safe Return to Play Following Surgery for Labral Repair: Development and Validation of a Return to Play Checklist
This study will try to develop and determine objective and validated criteria for our athletes to safely return to sports after labral repair.
- Conditions
- Labral Tear, Glenoid
- Being tested
- Safe return to play checklist
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe return to play checklistOther
this objective checklist will be utilized by the physical therapy staff and surgeon to determine whether an athlete is safe to return to their sport
| Study group | Role | What they receive |
|---|---|---|
| Utilization of a safe return to play checklist | Athletes who were treated for a capsulolabral tear who have undergone arthroscopic capsulolabral repair surgery will be evaluated using an objective checklist prior to being allowed to return to their sport. The utilization and outcome of using this checklist will be evaluated Receives: Other: Safe return to play checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of the return to play checklist
This outcome measure will count the number of patients who meet all the criteria in the return to play checklist prior to returning to their sport
Measured: 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start14 May 2018
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labral Tear, GlenoidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278716
- Sponsor's protocol ID
- 2020 TJ 04
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Return to Play Following Surgery for Labral Repair: Development and Validation of a Return to Play Checklist
- ClinicalTrials.gov ID
- NCT04278716
- Acronym / sponsor ID
- 2020 TJ 04
- Conditions
- Labral Tear, Glenoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 20 Feb 2020 (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.
This study will try to develop and determine objective and validated criteria for our athletes to safely return to sports after labral repair.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Utilization of a safe return to play checklist | – | Other: Safe return to play checklistAthletes who were treated for a capsulolabral tear who have undergone arthroscopic capsulolabral repair surgery will be evaluated using an objective checklist prior to being allowed to return to their sport. The utilization and outcome of using this checklist will be evaluated |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All athletes undergoing arthroscopic capsulolabral repair surgery will be eligible for participation
Key inclusion criteria (1 listed)
- Males and non-pregnant females aged 15 years or older with a capsulolabral tear undergoing arthroscopic capsulolabral repair surgery at the Rothman Institute with one of the investigators
Key exclusion criteria (7 listed)
- Patients with an labral repair
- Patients only undergoing debridements with no repair
- Patients undergoing revision shoulder surgery or those with a history of multiple shoulder surgeries
- Concomitant severe glenohumeral arthritis or adhesive capsulitis
- Patients with a worker's compensation claim
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 |
|---|---|---|
| Safe return to play checklistthis objective checklist will be utilized by the physical therapy staff and surgeon to determine whether an athlete is safe to return to their sport | Other | Utilization of a safe return to play checklist |
Primary outcome
Successful completion of the return to play checklist
Time frame: 1 year post-surgery
This outcome measure will count the number of patients who meet all the criteria in the return to play checklist prior to returning to their sport
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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 Labral Tear, Glenoid, run by Rothman Institute Orthopaedics at 1 site in United States.
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 1 inclusion and 7 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 20 Feb 2020. 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 United States. 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?
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?
Successful completion of the return to play checklist (time frame: 1 year post-surgery). 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 20 Feb 2020.