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NCT02153177 Clinical Trial

The Effect of NSAIDs After a Rotator Cuff Repair Surgery.

Rotator Cuff Tear Clinical Trial

Official title:
The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02153177
Other study ID # IRB 14-0540
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date January 2015
Est. completion date December 2018

Study information
Verified date February 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Description:

Furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: - rotator cuff tear - age 45-75 years Exclusion Criteria: - diabetes - pregnancy - chronic kidney disease - liver cirrhosis - hematologic malignancy - alcohol abusing - drug abusing

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Rotator cuff repair
Arthroscopic procedure
Drug:
• Ibuprofen, Hydrocodone/Acetaminophen, 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/Acetaminophen
Hydrocodone/Acetaminophen is given for pain control after the surgery.

Locations
Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Ultrasound evaluation of retear rate Ultrasound evaluation of retear rate at 6 months after the procedure one year
See also
  Status Clinical Trial Phase
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Completed NCT03663036 - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis N/A
Suspended NCT03290196 - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics Phase 4
Active, not recruiting NCT03091075 - Oxandrolone Rotator Cuff Trial N/A
Completed NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair Phase 2/Phase 3
Completed NCT04566939 - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting NCT02716441 - Rotator Cuff Failure With Continuity
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Completed NCT02298023 - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear) Phase 2
Completed NCT01383239 - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs N/A
Completed NCT02850211 - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair Phase 4
Completed NCT01459536 - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear N/A
Completed NCT01170312 - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation N/A
Completed NCT01204606 - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA) N/A
Terminated NCT00936559 - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair Phase 1
Completed NCT00852657 - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff N/A
Active, not recruiting NCT00182299 - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS Phase 4
Recruiting NCT06120998 - Quality of Life After Arthroscopic Rotator Cuff Repair
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT02644564 - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries N/A