Operative vs. Non-Operative Treatment of Acute Ruptures o... | NCT01711307

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

NCT01711307

Sponsor

Mark Glazebrook

Status

Terminated

Last Update Posted

Jul 9, 2020Actual

Enrollment

220Estimated

Phase

Not Applicable

Conditions

Ruptured Achilles Tendon

Interventions

operative
non-operative

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2012Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Oct 11, 2012

First Submission Date that Met QC Criteria

Oct 18, 2012

First Posted Date

Oct 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2020

Last Update Posted Date

Jul 9, 2020Actual

Name	Class
Nova Scotia Health Authority	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-operative	Experimental	cast applied within 48 hours	Procedure: non-operative
operative	Active Comparator	cast applied within 48 hours and surgery within 14 days	Procedure: operative

Interventions

Name	Type	Description	Arm Group Labels	Other Names
operative	Procedure		operative
non-operative

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Mark Glazebrook, MD	Capital Health District Authority	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Halifax Infirmary		Halifax	Nova Scotia	B3H 3A7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

COA AAOS AOFAS

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided