NCT01631669

Brief Summary

Hypotheses: H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls. H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification. H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 3, 2012

Status Verified

June 1, 2012

Enrollment Period

3.1 years

First QC Date

June 27, 2012

Last Update Submit

June 29, 2012

Conditions

Ossification, Heterotopic

Keywords

OssificationHeterotopic Ossification

Outcome Measures

Primary Outcomes (1)

  • Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

    Incidence and severity of HO

    3 years

Secondary Outcomes (1)

  • Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

    3 years

Study Arms (2)

Celebrex

EXPERIMENTAL

Receive Celebrex

Drug: Celecoxib

Control

NO INTERVENTION

no placebo administered

Interventions

CelecoxibDRUG

200 mg Q 12 hours orally

Also known as: Celebrex
Celebrex

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
  • Extremity Wound ≥75cm2 requiring operative intervention
  • Minimal age of 18 years

You may not qualify if:

  • Coronary Artery Disease,
  • Diabetes Mellitus (IDDM or T2DM),
  • Peripheral Vascular Disease,
  • Age \>65,
  • Connective tissue disorders,
  • Immunosuppression,
  • Clinically-evident peptic ulcer disease,
  • Substantial renal dysfunction (as assessed by a serum creatinine \>1.5 or calculated creatinine clearance of \<50),
  • Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC,
  • Severe penetrating or hemorrhagic traumatic brain injury,
  • Endoscopic gastrointestinal interventions,
  • Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
  • Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
  • History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
  • Hepatic Impairment
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Walter Reen National Military Medical Center Bethesda

Bethesda, Maryland, 20889, United States

RECRUITING

Landstuhl Military Medical Center

Landstuhl, Germany

RECRUITING

Related Publications (2)

  • Forsberg JA, Pepek JM, Wagner S, Wilson K, Flint J, Andersen RC, Tadaki D, Gage FA, Stojadinovic A, Elster EA. Heterotopic ossification in high-energy wartime extremity injuries: prevalence and risk factors. J Bone Joint Surg Am. 2009 May;91(5):1084-91. doi: 10.2106/JBJS.H.00792.

    PMID: 19411456BACKGROUND

  • Potter BK, Burns TC, Lacap AP, Granville RR, Gajewski DA. Heterotopic ossification following traumatic and combat-related amputations. Prevalence, risk factors, and preliminary results of excision. J Bone Joint Surg Am. 2007 Mar;89(3):476-86. doi: 10.2106/JBJS.F.00412.

    PMID: 17332095BACKGROUND

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jonathan A Forsberg, MD

    Walter Reed National Military Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan A Forsberg, MD

CONTACT

301-319-3403jonathan.forsberg@med.navy.mil

Frederick A Gage

CONTACT

301-319-8592frederick.gage@med.navy.mil

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

June 29, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2018

Last Updated

July 3, 2012

Record last verified: 2012-06

Locations

US(1)DE(1)