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

NCT01711307 | Terminated

• 1 other identifier: Version1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Ruptured Achilles Tendon

Keywords

Achilles; Rupture

Outcome Measures

Primary Outcomes (1)

• 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 (1)

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

  2 year

Study Arms (2)

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

operative PROCEDURE

operative

non-operative PROCEDURE

casting within 48 hrs

non-operative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mark Glazebrook: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Dr. Mark Glazebrook, MD

  Capital Health District Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c)

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)