CompletedEarly Phase 1

Influence of Naproxen on Heterotropic Bone Formation Following Hip Arthroscopy

United States108 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 75 days after surgery

Trial details

NCT IDNCT01539447

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-16

View on ClinicalTrials.gov More Heterotopic Ossification trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.