NCT02153177

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

3.9 years

First QC Date

May 29, 2014

Last Update Submit

February 21, 2023

Conditions

Rotator Cuff Tear

Keywords

Randomized Controlled Trial (RCT)RCTrotator cuff tearNSAIDsnon-steroidal anti-inflammatory drugsrotator cuff repair

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (1)

  • Ultrasound evaluation of retear rate

    one year

Study Arms (2)

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.

Procedure: Rotator cuff repairDrug: 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.

Procedure: Rotator cuff repairDrug: Hydrocodone/Acetaminophen

Interventions

Rotator cuff repairPROCEDURE

Arthroscopic procedure

Also known as: Rotator cuff repair procedure
NSAID and pain medication armpain medication arm
Ibuprofen, Hydrocodone/Acetaminophen, OmeprazoleDRUG

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.

Also known as: Motrin, Advil (Ibuprofen), Norco (Hydrocodone/Acetaminophen), Prilosec (Omeprazole)
NSAID and pain medication arm
Hydrocodone/AcetaminophenDRUG

Hydrocodone/Acetaminophen is given for pain control after the surgery.

Also known as: Norco
pain medication arm

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • rotator cuff tear
  • age 45-75 years

You may not qualify if:

  • diabetes
  • pregnancy
  • chronic kidney disease
  • liver cirrhosis
  • hematologic malignancy
  • alcohol abusing
  • drug abusing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

IbuprofenHydrocodoneAcetaminophenOmeprazoleoxycodone-acetaminophen

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAmines2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingBenzimidazolesHeterocyclic Compounds, 2-Ring

Study Officials

  • Lewis L Shi, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

US(1)