NCT02850211

Brief Summary

Selective cyclooxygenase (COX)-2 inhibitors are commonly used analgesics that provide similar analgesia but reduced adverse effects compared to other analgesics. However, few studies have been conducted on postoperative pain and tendon-to-bone healing. Here, the investigators investigated the effect of a selective COX-2 inhibitor on analgesia and tendon-to-bone healing following arthroscopic rotator cuff repair.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_4

Status
completed

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

Study Start

First participant enrolled

September 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

4.2 years

First QC Date

July 21, 2016

Last Update Submit

July 28, 2016

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

  • Rotator cuff healing failure

    Assessed by a musculoskeletal radiologist using MRI and ultrasonography

    Day 730

Secondary Outcomes (6)

  • Pain VAS score

    Day 0, Day 3, Day 14 Day 730

  • Medication satisfaction VAS score

    Day 0, Day 3 and Day 14

  • Adverse effects

    Day 3 and Day 14

  • Constant-Murley Shoulder score

    Day 730

  • American Shoulder and Elbow Surgeons score

    Day 730

  • +1 more secondary outcomes

Study Arms (3)

Celecoxib

EXPERIMENTAL

1 capsule of 200mg Celebrex twice a day for 14 days

Drug: Celecoxib

Traditional NSAIDs

ACTIVE COMPARATOR

1 tablet of 385mg Ibuprofen twice a day for 14 days

Drug: Ibuprofen

Opioid drug

ACTIVE COMPARATOR

1 tablet of 50mg Tramadol twice a day for 14 days

Drug: Tramadol

Interventions

CelecoxibDRUG

1 capsule of 200mg Celebrex PO(per oral) twice a day for 14 days

Also known as: Celebrex
Celecoxib
IbuprofenDRUG

1 tablet of 385mg Ibuprofen PO(per oral) twice a day for 14 days

Also known as: Carol-F
Traditional NSAIDs
TramadolDRUG

1 tablet of 50mg Tramadol PO(per oral) twice a day for 14 days

Also known as: Tridol
Opioid drug

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo arthroscopic acromioplasty and rotator cuff repair for a partial or full thickness tear
  • Age \< 80 years at time of diagnosis
  • Patient willing and able to comply with the study prescriptions
  • Patient able to give written informed consent before patient registration/randomisation

You may not qualify if:

  • Patients with rotator cuff tear arthropathy
  • Severe osteoarthritis (Samilson-Prieto grade II or higher)
  • Rheumatoid arthritis
  • Chronic renal failure (i.e., at high risk for the use of NSAIDs or opioid drugs)
  • Liver failure
  • Myocardial infarction or chronic heart failure
  • Cerebral vascular disease
  • Active gastric ulcer or bleeding
  • Allergies to NSAIDs or opioid drugs
  • Previous surgery on the same side
  • Pregnant or breast feeding patients
  • Those not willing to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Oh JH, Seo HJ, Lee YH, Choi HY, Joung HY, Kim SH. Do Selective COX-2 Inhibitors Affect Pain Control and Healing After Arthroscopic Rotator Cuff Repair? A Preliminary Study. Am J Sports Med. 2018 Mar;46(3):679-686. doi: 10.1177/0363546517744219. Epub 2017 Dec 18.

    PMID: 29253346DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

CelecoxibIbuprofenTramadol

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Joo Han Oh, MD, PhD

    Seoul National University Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 29, 2016

Study Start

September 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 29, 2016

Record last verified: 2016-07