TerminatedNot Applicable

Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon

Canada220 participantsStarted 2012-10-01

Plain-language summary

The proposed trial is a multi-centre prospective randomized controlled trial comparing outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or with open operative tendon repair. All patients will undergo accelerated functional rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.

Who can participate

Age range

18 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: * Complete mid-substance rupture of the Achilles tendon as diagnosed on clinical exam * Present for initial assessment and treatment with application of a plantar-flexed cast within 48 hours of their injury. * Referred to one of the participating orthopaedics surgeons in a timely fashion so as to allow for further treatment (operative repair or initiation of the rehabilitation protocol) within 14 days of their injury. Exclusion Criteria: * Open Achilles injury * Achilles injury that is not a mid-substance tendon injury * Any additional injury to the ipsilateral lower extremity * Contraindication to surgery or anesthetic * (Physical or mental) that may interfere with compliance with the rehabilitation protocol * Any known factor for increased risk of Achilles tendon rupture (i.e. diabetes mellitus, immunosuppressive therapy including local or systemic steroids, and fluoroquinolone use).

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

Operative vs non operative Treatment of acute ruptures of Achilles tendon.

Timeframe: 1 year

Trial details

NCT IDNCT01711307

SponsorMark Glazebrook

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Ruptured Achilles Tendon trials