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

Mark Glazebrook

Status

Terminated

Conditions

Ruptured Achilles Tendon

Treatments

Procedure: non-operative

Procedure: operative

Study type

Interventional

Funder types

Other

Identifiers

NCT01711307

Version1

Details and patient eligibility

About

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.

Full description

Equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects through elimination of a surgical repair; reduction of cost to patients by eliminating need for surgery.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).