Rotator Cuff TearsNCT04277208
Opioid-Free Study in Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Tears, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 1 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing ARCR will be asked to participate in this survey study
Who may be able to join
- All patients over the age of 18
- clinically indicated for an Arthroscopic Rotator Cuff Repair (ARCR)
Who cannot join
- Patients with irreparable rotator cuff tears
- allergic or sensitivity to the study medication
- intolerance to pain protocol
- history of gastrointestinal issues
- renal disease
- any evidence of glenohumeral arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial
The purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair.
- Conditions
- Rotator Cuff Tears
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Rotator Cuff Repair | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fulfill oxycodone prescription
data collected to the time from surgery until the patient chooses to fulfill a prescription for opioid medication following surgery
Measured: within first 3 days of surgery
Secondary outcomes (2)
VAS pain (Visual Analog Scale)
patient-reported pain as measured on a scale from 0-10. Zero means no pain and 10 being worst pain imaginable
Measured: Post-operative day 3
Patient satisfaction
Patient will be asked on a 5 point likert scale to rate their satisfaction with their post-operative pain regime
Measured: Post-operative day 3
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 start13 Jun 2018
- Primary completion13 Dec 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277208
- Sponsor's protocol ID
- 2018LAustin
- Status last verified
- Feb 2020
- First submitted
- 5 Aug 2019
- Last updated
- 20 Feb 2020
- Results posted
- 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 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT04277208
- Acronym / sponsor ID
- 2018LAustin
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- 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.
The purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Rotator Cuff Repair | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing ARCR will be asked to participate in this survey study
Key inclusion criteria (2 listed)
- All patients over the age of 18
- clinically indicated for an Arthroscopic Rotator Cuff Repair (ARCR)
Key exclusion criteria (6 listed)
- Patients with irreparable rotator cuff tears
- allergic or sensitivity to the study medication
- intolerance to pain protocol
- history of gastrointestinal issues
- renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to fulfill oxycodone prescription
Time frame: within first 3 days of surgery
data collected to the time from surgery until the patient chooses to fulfill a prescription for opioid medication following surgery
2 secondary outcomes
VAS pain (Visual Analog Scale)
Time frame: Post-operative day 3
Patient satisfaction
Time frame: Post-operative day 3
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 20 Feb 2020.
- 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 Rotator Cuff Tears, 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 2 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 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?
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?
Time to fulfill oxycodone prescription (time frame: within first 3 days of 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.