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

Sponsor

Mark Glazebrook (Other)

Overall Status

Terminated

CT.gov ID

NCT01711307

Collaborator

Nova Scotia Health Authority (Other)

220

Enrollment

Location

Arms

92.9

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ruptured Achilles Tendon	Procedure: operative Procedure: non-operative	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: non-operative cast applied within 48 hours	Procedure: non-operative casting within 48 hrs
Active Comparator: operative cast applied within 48 hours and surgery within 14 days	Procedure: operative

Arm

Intervention/Treatment

Experimental: non-operative

cast applied within 48 hours

Procedure: non-operative

casting within 48 hrs

Active Comparator: operative

cast applied within 48 hours and surgery within 14 days

Procedure: operative

Outcome Measures

Primary Outcome Measures

Operative vs non operative Treatment of acute ruptures of Achilles tendon. [1 year]
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 [2 year]
1. The Achilles tendon Total Rupture Score (ATRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Halifax Infirmary	Halifax	Nova Scotia	Canada	B3H 3A7

Sponsors and Collaborators

Mark Glazebrook
Nova Scotia Health Authority

Investigators

Principal Investigator: Dr. Mark Glazebrook, MD, Capital Health District Authority

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mark Glazebrook, Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c), Nova Scotia Health Authority

ClinicalTrials.gov Identifier:

NCT01711307

Other Study ID Numbers:

Version1

First Posted:

Oct 22, 2012

Last Update Posted:

Jul 9, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Mark Glazebrook, Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c), Nova Scotia Health Authority

Achilles

Rupture

Additional relevant MeSH terms:

Rupture

Study Results

No Results Posted as of Jul 9, 2020