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

NCT ID: NCT01711307

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Ruptured Achilles Tendon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-operative

cast applied within 48 hours

Group Type EXPERIMENTAL

non-operative

Intervention Type PROCEDURE

casting within 48 hrs

operative

cast applied within 48 hours and surgery within 14 days

Group Type ACTIVE_COMPARATOR

operative

Intervention Type PROCEDURE

Interventions

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operative

Intervention Type PROCEDURE

non-operative

casting within 48 hrs

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role collaborator

Mark Glazebrook

OTHER

Sponsor Role lead

Responsible Party

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Mark Glazebrook

Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dr. Mark Glazebrook, MD

Role: PRINCIPAL_INVESTIGATOR

Capital Health District Authority

Locations

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Halifax Infirmary

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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Version1

Identifier Type: -

Identifier Source: org_study_id

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