Ruptured Achilles TendonAchillesRCTNCT01711307
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
A study testing operative and non-operative in people with Ruptured Achilles Tendon, run by Mark Glazebrook at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ruptured Achilles Tendon
- What is being tested?
- operative and non-operative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2012to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Ruptured Achilles Tendon
- Being tested
- operative, non-operative
- Keywords
- Achilles, Rupture
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operativeProcedure or surgery
non-operativeProcedure or surgery
casting within 48 hrs
| Study group | Role | What they receive |
|---|---|---|
| non-operative | Experimental | cast applied within 48 hours Receives: Procedure: non-operative |
| operative | Active comparator | cast applied within 48 hours and surgery within 14 days Receives: Procedure: operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative vs non operative Treatment of acute ruptures of Achilles tendon.
The primary outcome measure is Achilles tendon re-rupture rate
Measured: 1 year
Secondary outcomes (1)
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
- The Achilles tendon Total Rupture Score (ATRS)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study start1 Oct 2012
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Achilles TendonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Glazebrook
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Mark Glazebrook, Nova Scotia Health Authority
- Investigators
- Dr. Mark Glazebrook, MD, Principal investigator, Capital Health District Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711307
- Sponsor's protocol ID
- Version1
- Acronym
- AchillesRCT
- Status last verified
- Jul 2020
- First submitted
- 11 Oct 2012
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: COA AAOS AOFAS
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01711307
- Acronym / sponsor ID
- AchillesRCT / Version1
- Conditions
- Ruptured Achilles Tendon
- Keywords
- Achilles, Rupture
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Mark GlazebrookUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-operative | Experimental | Procedure: non-operativecast applied within 48 hours |
| operative | Active comparator | Procedure: operativecast applied within 48 hours and surgery within 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| operative | Procedure or surgery | operative |
| non-operativecasting within 48 hrs | Procedure or surgery | non-operative |
Primary outcome
Operative vs non operative Treatment of acute ruptures of Achilles tendon.
Time frame: 1 year
The primary outcome measure is Achilles tendon re-rupture rate
1 secondary outcome
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
Time frame: 2 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: Yes. COA AAOS AOFAS
Related trials for Ruptured Achilles Tendon
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Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
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Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
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Achilles Tendon Rupture Patient Outcomes at 12 Months
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Effect of BFR Rehab After Achilles Tendon Rupture
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Mark Glazebrook, MD principal investigator
Capital Health District Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing operative and non-operative in people with Ruptured Achilles Tendon, run by Mark Glazebrook at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative vs non operative Treatment of acute ruptures of Achilles tendon. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.