Rotator Cuff TearPhase 4NCT02153177
The Effect of NSAIDs After a Rotator Cuff Repair Surgery.
A Phase 4 study testing Rotator cuff repair, Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole and Hydrocodone/Acetaminophen in people with Rotator Cuff Tear, run by University of Chicago at 1 site in United States.
Trial summary
The main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Rotator cuff repair, Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole and Hydrocodone/Acetaminophen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2018
- Phase
- Phase 4
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rotator cuff tear
- age 45-75 years
Who cannot join
- diabetes
- pregnancy
- chronic kidney disease
- liver cirrhosis
- hematologic malignancy
- alcohol abusing
- drug abusing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial
The main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure.
Read the detailed description
Furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.
- Conditions
- Rotator Cuff Tear
- Being tested
- Rotator cuff repair, Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole, Hydrocodone/Acetaminophen
- Keywords
- Randomized Controlled Trial (RCT), RCT, rotator cuff tear, NSAIDs, non-steroidal anti-inflammatory drugs, rotator cuff repair
- 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.
Rotator cuff repairProcedure or surgery
Also called Rotator cuff repair procedure
Arthroscopic procedure
Ibuprofen, Hydrocodone/Acetaminophen, OmeprazoleDrug
Also called Motrin, Advil (Ibuprofen), Norco (Hydrocodone/Acetaminophen), Prilosec (Omeprazole)
In addition to pain medication after the procedure patients will receive Ibuprofen and Omeprazole. Omeprazole is given to minimize the gastrointestinal side effects of Ibuprofen.
Hydrocodone/AcetaminophenDrug
Also called Norco
Hydrocodone/Acetaminophen is given for pain control after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| NSAID and pain medication arm | Active comparator | After a rotator cuff repair procedure subjects in the NSAID and pain medication arm will receive both Ibuprofen and Hydrocodone/Acetaminophen, and also Omeprazole. Receives: Procedure: Rotator cuff repair; Drug: Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole |
| pain medication arm | Active comparator | Patients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure. Receives: Procedure: Rotator cuff repair; Drug: Hydrocodone/Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
Measured: one year
Secondary outcomes (1)
Ultrasound evaluation of retear rate
Ultrasound evaluation of retear rate at 6 months after the procedure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: The study was withdrawn prior to any participants being enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lewis L Shi, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153177
- Sponsor's protocol ID
- IRB 14-0540
- Status last verified
- Feb 2023
- First submitted
- 29 May 2014
- Last updated
- 23 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02153177
- Acronym / sponsor ID
- IRB 14-0540
- Conditions
- Rotator Cuff Tear
- Keywords
- Randomized Controlled Trial (RCT), RCT, rotator cuff tear, NSAIDs, non-steroidal anti-inflammatory drugs, rotator cuff repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to any participants being enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 2 Jun 2014 (estimated)
- 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 main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure.
Detailed description
Furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID and pain medication arm | Active comparator | Procedure: Rotator cuff repair, Drug: Ibuprofen, Hydrocodone/Acetaminophen, OmeprazoleAfter a rotator cuff repair procedure subjects in the NSAID and pain medication arm will receive both Ibuprofen and Hydrocodone/Acetaminophen, and also Omeprazole. |
| pain medication arm | Active comparator | Procedure: Rotator cuff repair, Drug: Hydrocodone/AcetaminophenPatients in the pain medication arm will receive Hydrocodone/Acetaminophen after the rotator cuff repair procedure. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- rotator cuff tear
- age 45-75 years
Key exclusion criteria (7 listed)
- diabetes
- pregnancy
- chronic kidney disease
- liver cirrhosis
- hematologic malignancy
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 |
|---|---|---|
| Rotator cuff repairAlso: Rotator cuff repair procedureArthroscopic procedure | Procedure or surgery | NSAID and pain medication arm, pain medication arm |
| Ibuprofen, Hydrocodone/Acetaminophen, OmeprazoleAlso: Motrin, Advil (Ibuprofen), Norco (Hydrocodone/Acetaminophen), Prilosec (Omeprazole)In addition to pain medication after the procedure patients will receive Ibuprofen and Omeprazole. Omeprazole is given to minimize the gastrointestinal side effects of Ibuprofen. | Drug | NSAID and pain medication arm |
| Hydrocodone/AcetaminophenAlso: NorcoHydrocodone/Acetaminophen is given for pain control after the surgery. | Drug | pain medication arm |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: one year
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
1 secondary outcome
Ultrasound evaluation of retear rate
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
Lewis L Shi, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotator cuff repair, Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole and Hydrocodone/Acetaminophen in people with Rotator Cuff Tear, run by University of Chicago 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 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: withdrawn, as of the sponsor's last update on 23 Feb 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
American Shoulder and Elbow Surgeons (ASES) Shoulder Score (time frame: one year). 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 23 Feb 2023.