NCT01539447

Brief Summary

In a brief summary the study would like to evaluate the effectiveness of Naproxen in preventing radiographically detected heterotopic ossification following hip arthroscopy for the treatment of femoroacetabular impingement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2012

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

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

January 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

10.2 years

First QC Date

January 12, 2012

Last Update Submit

July 11, 2022

Conditions

Heterotopic Ossification

Keywords

Hip arthroscopyFemoroacetabular impingementHeterotopic ossificationHeterotopic bone formation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with documented Heterotopic Ossification (HO) in the Naproxen group vs Placebo group

    The hypothesis is that there will be fewer instances of HO in the Naproxen group compared to the Placebo group.

    75 days after surgery

Secondary Outcomes (1)

  • Number of participants with adverse events in the Naproxen group vs Placebo group.

    Data outcome collected 4 weeks post operatively

Study Arms (2)

Naproxen

ACTIVE COMPARATOR

• Group 1: Naproxen 500 mg twice daily for three weeks following surgery beginning postoperative day #1

Drug: Naproxen

Placebo

PLACEBO COMPARATOR

• Group 2: Placebo twice daily for three weeks following surgery beginning postoperative day #1

Drug: placebo

Interventions

NaproxenDRUG

• Group 1: Naproxen 500 mg twice daily for three weeks following surgery beginning postoperative day #1

Naproxen
placeboDRUG

• Group 2: Placebo twice daily for three weeks following surgery beginning postoperative day #1

Also known as: Placebo Control
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is 18-80 years of age.
  • The patient has provided written informed consent.
  • The patient is scheduled for hip arthroscopy surgery for treatment of FAI
  • The patient has an ASA of I, II, or III.
  • The patients understands the explanation of the protocol.

You may not qualify if:

  • The patient has history of a major GI bleeding event
  • The patients has a history of renal impairment or creatinine \> 1.5
  • The patient has taken NSAIDs within 48 hours of surgery or in the perioperative period
  • The patient has a history of heterotopic ossification following surgery
  • The patient has a hypersensitivity reaction to Naproxen
  • The patient is undergoing a concomitant procedure in addition to treatment of FAI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopedics Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • Beckmann JT, Wylie JD, Potter MQ, Maak TG, Greene TH, Aoki SK. Effect of Naproxen Prophylaxis on Heterotopic Ossification Following Hip Arthroscopy: A Double-Blind Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2015 Dec 16;97(24):2032-7. doi: 10.2106/JBJS.N.01156.

    PMID: 26677237DERIVED

MeSH Terms

Conditions

Ossification, HeterotopicFemoracetabular Impingement

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Stephen Aoki, M.D.

    University of Utah Orthopedics Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
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
M.D.

Study Record Dates

First Submitted

January 12, 2012

First Posted

February 27, 2012

Study Start

January 1, 2012

Primary Completion

March 16, 2022

Study Completion

March 16, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations

US(1)