Achilles TendonNCT02062567
Ultrasonographic Guided Treatment of Acute Achilles Tendon Rupture. Evaluation of Two Novel Ultrasonographic Measurements
An observational study of Achilles Tendon and Rupture, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
With this project the investigators wish to: 1. Test the reproducibility of Amlang's ultrasound classification by examining the intra- and inter-rater reliability. 2. Investigate whether Amlang's ultrasound classification is able to predict which patients are likely to develop complications when treated… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Achilles Tendon, Rupture, Ultrasound
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Jan 2018
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 130 patients who are treated for acute Achilles tendon rupture at Copenhagen University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to participate are treated according the standard regimen (non-operatively without early controlled movement of the ankle joint).
Who may be able to join
- Age 18-70 years.
- The patient must be expected to be able to attend rehabilitation and post-examinations.
- The patient must be able to speak and understand Danish.
- The patient must be able to give informed consent.
Who cannot join
- Former rupture of one or both Achilles tendon(s).
- Previous surgery on the Achilles tendon.
- Fluoroquinolone treatment within the last 6 months.
- Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.
- The patient has been diagnosed with arterial insufficiency in the legs.
- Terminal illness or severe medical illness: ASA score higher than or equal to 3.
- The space between the rupture and the calcaneus is less than 1cm.
Trial locations and contacts
1 site in 1 country.
About this study
With this project the investigators wish to:
- Test the reproducibility of Amlang's ultrasound classification by examining the intra- and inter-rater reliability.
- Investigate whether Amlang's ultrasound classification is able to predict which patients are likely to develop complications when treated non-operatively.
- Investigate whether Barfod's length measurement is able to predict which patients are likely to develop complications when treated non-operatively.
Read the detailed description
Study objectives
To validate Amlang's ultrasound classification and investigate whether the treatment of acute Achilles tendon ruptures (ATR) can be guided by:
- Amlang's ultrasound classification of ATR
- Barfod's ultrasound measurement to determine the elongation of the Achilles tendon following a rupture Backgrund A larger group of patients end up with a poor outcome after treatment for ATR. ATR is a frequent and potentially debilitating injury that typically affects young active adults (11 to 37 per 100,000)1 2 3. Consequently, there are great socioeconomic benefits in optimizing treatment and shortening time of recovery.
There is currently no consensus regarding the best treatment of ATR. Traditionally the operative treatment has been considered superior, however recent studies show that non-operative treatment is a safe treatment which leads to good results 4 5 6. For this reason a transition towards greater use of non-operative treatment is seen in many orthopedic departments 7.
Patients who end up with a poor result after treatment for ATR typically suffer from rerupture of the tendon or an elongation of the tendon. There is a 5-10 percent risk of rerupture 4 5 6. It is unknown how many patients heal with an elongation of the Achilles tendon. Correct length of the Achilles tendon is essential for the subsequent function of the tendon.
In order to shorten time of recovery and optimize the treatment-outcome, it is desirable to identify patients at risk of re-rupture or elongation as early as possible as early surgery might help these patients.
Amlang et al. have developed an ultrasonographic classification system to be used in the acute phase of rupture 8. The aim is to predict whether the patient will benefit from operative or non-operative treatment. The classification system appears well considered; however, the classification needs validation and to be correlated to outcome.
Barfod et al. have developed a method for measuring the prolongation of the Achilles tendon in the acute phase following a rupture. The length measurement has been validated using healthy subjects. Data are analyzed and publication is expected autumn 2013. It has not been tested whether the measurement works on torn Achilles tendons and whether there is a correlation between the measurement and outcome.
With this project the investigators wish to:
- Teste the reproducibility of Amlang's ultrasound classification by examining the intra- and inter-rater reliability.
- Investigate whether Amlang's ultrasound classification is able to predict which patients are likely to develop complications when treated non-operatively.
- Investigate whether Barfod's length measurement is able to predict which patients are likely to develop complications when treated non-operatively.
Study Design Type of study The study is carried out as a prospective cohort study. Time schedule The recruitment of patients will begin 1 of November 2013. It is expected that the study will be completed after 4-5 years; the recruitment itself is expected to span 2 years, provided that an average of 6 patients is included per month.
Discontinuation Each patient can choose to withdraw from the trial at any time. A patient may also be withdrawn from the trial at any time based on the investigators' discretion.
Method Amlang's ultrasound classification and Barfod's length measurement are determined as described below. For the initial 30 patients Amlang's ultrasound classification will be determined using two independent ultrasound-operators in order to test the inter-observer consistency.
Ultrasound - Set up The patient is in the prone position with the knees slightly flexed (10 -20 degrees). A triangular foam pad is placed below (anterior to) the ankle joints, so that the feet are resting limply. By moving the pad up (cranial) and down (caudal) the angle of the relaxed ankle joints is adjusted to 20 degrees plantar flexion. The angle is measured using a goniometer (the longitudinal axis of the fibula is at 110 degrees with the posterior part of the lateral border of the foot). The calf muscles are relaxed.
Amlang's ultrasound classification Amlang's ultrasound classification is conducted by determining the cross-sectional area of the widest point of the tendon below (distal to) the rupture (area-widest) and of the narrowest point at the rupture site (area-smallest). The ratio between "area-smallest" and "area-widest" is interpreted as a measure for the magnitude of overlap between the tendon ends. A ratio above 70 percent is considered as a total adaption of the tendon ends. A ratio of 30 to 70 percent is considered as a partial adaption of the tendon ends. And a ratio of less than 30 percent is considered as a lack of adaption of the tendon ends.
Barfod's length measurement Barfod's length measurement is conducted using a simple method that does not require expensive equipment or advanced instruments. A needle is placed between the skin and the ultrasonographic probe. The shadow of the needle then projects the internal structures to the skin surface and the distance between calcaneus and the medial head of the gastrocnemius muscle can then be measured.
Study Design Type of study The study is carried out as a prospective cohort study. Time schedule The recruitment of patients will begin 1 of November 2013. It is expected that the study will be completed after 4-5 years; the recruitment itself is expected to span 2 years, provided that an average of 6 patients is included per month.
Discontinuation Each patient can choose to withdraw from the trial at any time. A patient may also be withdrawn from the trial at any time based on the investigators' discretion.
Method Amlang's ultrasound classification and Barfod's length measurement are determined as described below. For the initial 30 patients Amlang's ultrasound classification will be determined using two independent ultrasound-operators in order to test the inter-observer consistency.
Ultrasound - Set up The patient is in the prone position with the knees slightly flexed (10 -20 degrees). A triangular foam pad is placed below (anterior to) the ankle joints, so that the feet are resting limply. By moving the pad up (cranial) and down (caudal) the angle of the relaxed ankle joints is adjusted to 20 degrees plantar flexion. The angle is measured using a goniometer (the longitudinal axis of the fibula is at 110 degrees with the posterior part of the lateral border of the foot). The calf muscles are relaxed.
Amlang's ultrasound classification Amlang's ultrasound classification is conducted by determining the cross-sectional area of the widest point of the tendon below (distal to) the rupture (area-widest) and of the narrowest point at the rupture site (area-smallest). The ratio between "area-smallest" and "area-widest" is interpreted as a measure for the magnitude of overlap between the tendon ends. A ratio above 70 percent is considered as a total adaption of the tendon ends. A ratio of 30 to 70 percent is considered as a partial adaption of the tendon ends. And a ratio of less than 30 percent is considered as a lack of adaption of the tendon ends.
Barfod's length measurement Barfod's length measurement is conducted using a simple method that does not require expensive equipment or advanced instruments. A needle is placed between the skin and the ultrasonographic probe. The shadow of the needle then projects the internal structures to the skin surface and the distance between calcaneus and the medial head of the gastrocnemius muscle can then be measured.
Statistics The groups will be described descriptively regarding demographic parameters as well as primary and secondary endpoints. The correlation between Amlang's ultrasound classification and the primary and secondary endpoints will be examined using a regression analysis. The correlation between Barfod's length measurement and the primary and secondary endpoints will be examined in the same way.
The research group The study is carried out as collaboration between the research unit, Clinical Orthopaedic Research Hvidovre (www.corh.dk) and the Department of Physical- and Occupational Therapy, both at Copenhagen University Hospital Hvidovre.
- Conditions
- Achilles Tendon, Rupture, Ultrasound
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Achilles tendon rupture | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corelation between Amlangs ultrasound classification or Barfods length meassure and ATRS
We whish to investigate if Amlangs ultrasound classification or Barfods length meassure can predict outcome after acute achilles tendon rupture. To do so both meassures will be correlated to ATRS (the Achilles tendon Total Rupture Score).
Measured: 1 year
Secondary outcomes (1)
Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Heel-rise-work test
We whish to investigate if Amlangs ultrasound classification or Barfods length meassure can predict outcome after acute achilles tendon rupture. To do so both meassures will be correlated to the heel-rise work test.
Heel-rise-work test: Endurance test where the patient stands on one leg and lifts the heel up and down until exhaustion. The number and the height of the heel-rises are counted and measured. The results are then compared to the weight of the patient and the total work is estimated. The MuscleLab ® (Ergo Test Technology, Oslo, Norway) measurement system is used.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DJO Incorporated, The Danish Rheumatism Association
- Responsible party
- Principal investigator, Kristoffer Barfod, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062567
- Sponsor's protocol ID
- ATR_US_Denmark_2014
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2014
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Guided Treatment of Acute Achilles Tendon Rupture. Evaluation of Two Novel Ultrasonographic Measurements
- ClinicalTrials.gov ID
- NCT02062567
- Acronym / sponsor ID
- ATR_US_Denmark_2014
- Conditions
- Achilles Tendon, Rupture, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- DJO Incorporated, The Danish Rheumatism Association
- Study start
- Feb 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 Feb 2014 (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.
With this project the investigators wish to:
- Test the reproducibility of Amlang's ultrasound classification by examining the intra- and inter-rater reliability.
- Investigate whether Amlang's ultrasound classification is able to predict which patients are likely to develop complications when treated non-operatively.
- Investigate whether Barfod's length measurement is able to predict which patients are likely to develop complications when treated non-operatively.
Detailed description
Study objectives
To validate Amlang's ultrasound classification and investigate whether the treatment of acute Achilles tendon ruptures (ATR) can be guided by:
- Amlang's ultrasound classification of ATR
- Barfod's ultrasound measurement to determine the elongation of the Achilles tendon following a rupture Backgrund A larger group of patients end up with a poor outcome after treatment for ATR. ATR is a frequent and potentially debilitating injury that typically affects young active adults (11 to 37 per 100,000)1 2 3. Consequently, there are great socioeconomic benefits in optimizing treatment and shortening time of recovery.
There is currently no consensus regarding the best treatment of ATR. Traditionally the operative treatment has been considered superior, however recent studies show that non-operative treatment is a safe treatment which leads to good results 4 5 6. For this reason a transition towards greater use of non-operative treatment is seen in many orthopedic departments 7.
Patients who end up with a poor result after treatment for ATR typically suffer from rerupture of the tendon or an elongation of the tendon. There is a 5-10 percent risk of rerupture 4 5 6. It is unknown how many patients heal with an elongation of the Achilles tendon. Correct length of the Achilles tendon is essential for the subsequent function of the tendon.
In order to shorten time of recovery and optimize the treatment-outcome, it is desirable to identify patients at risk of re-rupture or elongation as early as possible as early surgery might help these patients.
Amlang et al. have developed an ultrasonographic classification system to be used in the acute phase of rupture 8. The aim is to predict whether the patient will benefit from operative or non-operative treatment. The classification system appears well considered; however, the classification needs validation and to be correlated to outcome.
Barfod et al. have developed a method for measuring the prolongation of the Achilles tendon in the acute phase following a rupture. The length measurement has been validated using healthy subjects. Data are analyzed and publication is expected autumn 2013. It has not been tested whether the measurement works on torn Achilles tendons and whether there is a correlation between the measurement and outcome.
With this project the investigators wish to:
- Teste the reproducibility of Amlang's ultrasound classification by examining the intra- and inter-rater reliability.
- Investigate whether Amlang's ultrasound classification is able to predict which patients are likely to develop complications when treated non-operatively.
- Investigate whether Barfod's length measurement is able to predict which patients are likely to develop complications when treated non-operatively.
Study Design Type of study The study is carried out as a prospective cohort study. Time schedule The recruitment of patients will begin 1 of November 2013. It is expected that the study will be completed after 4-5 years; the recruitment itself is expected to span 2 years, provided that an average of 6 patients is included per month.
Discontinuation Each patient can choose to withdraw from the trial at any time. A patient may also be withdrawn from the trial at any time based on the investigators' discretion.
Method Amlang's ultrasound classification and Barfod's length measurement are determined as described below. For the initial 30 patients Amlang's ultrasound classification will be determined using two independent ultrasound-operators in order to test the inter-observer consistency.
Ultrasound - Set up The patient is in the prone position with the knees slightly flexed (10 -20 degrees). A triangular foam pad is placed below (anterior to) the ankle joints, so that the feet are resting limply. By moving the pad up (cranial) and down (caudal) the angle of the relaxed ankle joints is adjusted to 20 degrees plantar flexion. The angle is measured using a goniometer (the longitudinal axis of the fibula is at 110 degrees with the posterior part of the lateral border of the foot). The calf muscles are relaxed.
Amlang's ultrasound classification Amlang's ultrasound classification is conducted by determining the cross-sectional area of the widest point of the tendon below (distal to) the rupture (area-widest) and of the narrowest point at the rupture site (area-smallest). The ratio between "area-smallest" and "area-widest" is interpreted as a measure for the magnitude of overlap between the tendon ends. A ratio above 70 percent is considered as a total adaption of the tendon ends. A ratio of 30 to 70 percent is considered as a partial adaption of the tendon ends. And a ratio of less than 30 percent is considered as a lack of adaption of the tendon ends.
Barfod's length measurement Barfod's length measurement is conducted using a simple method that does not require expensive equipment or advanced instruments. A needle is placed between the skin and the ultrasonographic probe. The shadow of the needle then projects the internal structures to the skin surface and the distance between calcaneus and the medial head of the gastrocnemius muscle can then be measured.
Study Design Type of study The study is carried out as a prospective cohort study. Time schedule The recruitment of patients will begin 1 of November 2013. It is expected that the study will be completed after 4-5 years; the recruitment itself is expected to span 2 years, provided that an average of 6 patients is included per month.
Discontinuation Each patient can choose to withdraw from the trial at any time. A patient may also be withdrawn from the trial at any time based on the investigators' discretion.
Method Amlang's ultrasound classification and Barfod's length measurement are determined as described below. For the initial 30 patients Amlang's ultrasound classification will be determined using two independent ultrasound-operators in order to test the inter-observer consistency.
Ultrasound - Set up The patient is in the prone position with the knees slightly flexed (10 -20 degrees). A triangular foam pad is placed below (anterior to) the ankle joints, so that the feet are resting limply. By moving the pad up (cranial) and down (caudal) the angle of the relaxed ankle joints is adjusted to 20 degrees plantar flexion. The angle is measured using a goniometer (the longitudinal axis of the fibula is at 110 degrees with the posterior part of the lateral border of the foot). The calf muscles are relaxed.
Amlang's ultrasound classification Amlang's ultrasound classification is conducted by determining the cross-sectional area of the widest point of the tendon below (distal to) the rupture (area-widest) and of the narrowest point at the rupture site (area-smallest). The ratio between "area-smallest" and "area-widest" is interpreted as a measure for the magnitude of overlap between the tendon ends. A ratio above 70 percent is considered as a total adaption of the tendon ends. A ratio of 30 to 70 percent is considered as a partial adaption of the tendon ends. And a ratio of less than 30 percent is considered as a lack of adaption of the tendon ends.
Barfod's length measurement Barfod's length measurement is conducted using a simple method that does not require expensive equipment or advanced instruments. A needle is placed between the skin and the ultrasonographic probe. The shadow of the needle then projects the internal structures to the skin surface and the distance between calcaneus and the medial head of the gastrocnemius muscle can then be measured.
Statistics The groups will be described descriptively regarding demographic parameters as well as primary and secondary endpoints. The correlation between Amlang's ultrasound classification and the primary and secondary endpoints will be examined using a regression analysis. The correlation between Barfod's length measurement and the primary and secondary endpoints will be examined in the same way.
The research group The study is carried out as collaboration between the research unit, Clinical Orthopaedic Research Hvidovre (www.corh.dk) and the Department of Physical- and Occupational Therapy, both at Copenhagen University Hospital Hvidovre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Achilles tendon rupture | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 130 patients who are treated for acute Achilles tendon rupture at Copenhagen University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to participate are treated according the standard regimen (non-operatively without early controlled movement of the ankle joint).
Key inclusion criteria (4 listed)
- Age 18-70 years.
- The patient must be expected to be able to attend rehabilitation and post-examinations.
- The patient must be able to speak and understand Danish.
- The patient must be able to give informed consent.
Key exclusion criteria (7 listed)
- Former rupture of one or both Achilles tendon(s).
- Previous surgery on the Achilles tendon.
- Fluoroquinolone treatment within the last 6 months.
- Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.
- The patient has been diagnosed with arterial insufficiency in the legs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corelation between Amlangs ultrasound classification or Barfods length meassure and ATRS
Time frame: 1 year
We whish to investigate if Amlangs ultrasound classification or Barfods length meassure can predict outcome after acute achilles tendon rupture. To do so both meassures will be correlated to ATRS (the Achilles tendon Total Rupture Score).
1 secondary outcome
Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Heel-rise-work test
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon and Rupture, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 27 Feb 2018. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Corelation between Amlangs ultrasound classification or Barfods length meassure and ATRS (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 27 Feb 2018.