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

Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon: A Multi-centered Randomized Control Trial Using Standardized Objective and Subjective Outcome Measurement to Determine Rerupture Rate.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01711307

Acronym

AchillesRCT

Enrollment

220

Registered

2012-10-22

Start date

2012-10-01

Completion date

2020-06-30

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ruptured Achilles Tendon

Keywords

Achilles, Rupture

Brief 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.

Detailed 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.

Interventions

PROCEDUREoperative

PROCEDUREnon-operative

casting within 48 hrs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Operative vs non operative Treatment of acute ruptures of Achilles tendon.	1 year	The primary outcome measure is Achilles tendon re-rupture rate

Secondary

Measure	Time frame	Description
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon	2 year	1\. The Achilles tendon Total Rupture Score (ATRS)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026