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

Primary Purpose

Ruptured Achilles Tendon

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
operative
non-operative
Sponsored by
Mark Glazebrook
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ruptured Achilles Tendon focused on measuring Achilles, Rupture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Halifax Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

non-operative

operative

Arm Description

cast applied within 48 hours

cast applied within 48 hours and surgery within 14 days

Outcomes

Primary Outcome Measures

Operative vs non operative Treatment of acute ruptures of Achilles tendon.
The primary outcome measure is Achilles tendon re-rupture rate

Secondary Outcome Measures

Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
1. The Achilles tendon Total Rupture Score (ATRS)

Full Information

First Posted
October 11, 2012
Last Updated
July 7, 2020
Sponsor
Mark Glazebrook
Collaborators
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01711307
Brief Title
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
Acronym
AchillesRCT
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Glazebrook
Collaborators
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ruptured Achilles Tendon
Keywords
Achilles, Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non-operative
Arm Type
Experimental
Arm Description
cast applied within 48 hours
Arm Title
operative
Arm Type
Active Comparator
Arm Description
cast applied within 48 hours and surgery within 14 days
Intervention Type
Procedure
Intervention Name(s)
operative
Intervention Type
Procedure
Intervention Name(s)
non-operative
Intervention Description
casting within 48 hrs
Primary Outcome Measure Information:
Title
Operative vs non operative Treatment of acute ruptures of Achilles tendon.
Description
The primary outcome measure is Achilles tendon re-rupture rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
Description
1. The Achilles tendon Total Rupture Score (ATRS)
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Mark Glazebrook, MD
Organizational Affiliation
Capital Health District Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
COA AAOS AOFAS

Learn more about this trial

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

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