Achilles Tendon RuptureNCT05614908
Outcome After Conservatively Treated Achilles Tendon Rupture
An observational study of Achilles Tendon Rupture and Achilles Tendon Injury, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The main purpose of the study is to compare the patient-reported outcomes and adverse events of two different rehabilitation regimes for patients undergoing non-surgical treatment of Achilles Tendon Rupture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendon Rupture, Achilles Tendon Injury
- What is being tested?
- 11 week restrictive regime and 8 week liberal regime
- How many people
- 220 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2022to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population consists of approx. 220 consecutive acute achilles tendon rupture patients, treated non-surgically at Aarhus University Hospital from 2022 to approximately 2028.
Who may be able to join
- Patients with an acute achilles tendon rupture treated non-surgically at AUH
- Treatment start maximum 14 days after time of rupture
- ≥18 years
- Understand and read Danish
Who cannot join
- Patients who have not followed the regime at AUH (e.g. terminated use of the ROM- walker prematurely or similar)
- Bilateral ATR or rupture of the opposite in the treatmentperiod
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nonsurgical Treatment of Achilles Tendon Rupture: Comparison of an 8-week Liberal Regime With an 11-week Restrictive Regime. A Prospective Cohort Quality Assurance Study.
The main purpose of the study is to compare the patient-reported outcomes and adverse events of two different rehabilitation regimes for patients undergoing non-surgical treatment of Achilles Tendon Rupture. Thus, using a pre-post study design we will compare whether patients participating in an 8-week liberal rehabilitation regime will achieve the same, or better, self- reported functional ability, without increased risk of adverse events, in the first two years following injury, compared to an 11 weeks more restrictive rehabilitation regime..
Read the detailed description
Background:
The Achilles tendon is the most commonly injured tendon in the lower extremity, and can be treated either surgical or non-surgical. Previous studies have investigated early controlled motion and weight-bearing for non-surgically treated Achilles Tendon Rupture (ATR). Early motion may cause tendon elongation, which leads to decrease in push off strength, and thus potentially a poorer functional outcome. Conversely, delayed initiation of mobilisation and weight-bearing may similarly hinder or delay optimal recovery of function and return to work and sports. The correct treatment and rehabilitation, including the timing of rehabilitation initiation, may therefore be crucial to ensure the patients functional ability.
Most hospitals in Denmark treating patients with ATR, provide a regime of 8-9 weeks of treatment for non-surgically treated patients. At Aarhus University Hospital (AUH), however, a more restrictive regime has been provided for these patients in the past 7 years, with a treatment period of 11 weeks after injury, and with no or limited weight-bearing or exercises.
A previous retrospective study at AUH including 100 patients undergoing non-surgical treatment and the restrictive 11 week rehabilitation regime was conducted in 2023. The results documented a re-rupture rate of 4 %, comparable to the rate reported at the Danish ATR Database, and similarly comparable results on patient-reported disability measured with the Achilles tendon Total Rupture Score (ATRS). The Danish ATR Database includes data from 11 different hospitals in Denmark, where the majority have implemented a more liberal rehabilitation regime of 8-9 weeks of treatment with early weight-bearing and exercises. As a result of this retrospective study, we are changing the rehabilitation protocol of ATR at AUH, from 11 weeks restrictive regime, to an 8 weeks liberal regime.
Purpose:
With this quality assurance study we aim to compare patient-reported outcomes and adverse events in patients participating in an 8-week liberal regime compared to an 11-week restrictive regime following non-surgically treated ATR
Study design and setting:
This is an observational cohort study with prospectively collected patient-reported outcomes, conducted at AUH. First, 110 consecutive patients will be included while the existing 11-week restrictive regime is standard care, then the 8-week liberal regime will be implemented, and subsequently another 110 patients will be consecutively included.
Data collection procedures and outcomes:
Patients will receive a digital letter with a link to an online questionnaire to be completed at 6 months, 12 months and 24 months from the date of the treatment start.
Patients are asked to fill out the ATRS on functional ability, as well as additional questions regarding job status, return to sport, incidence of deep venous thrombosis, whether they have sustained a re-rupture, and their satisfaction with treatment they received at the hospital.
The ATRS is a 10-item questionnaire, with a score of 0 to 10 (worst-best), which has been found valid, reliable and responsive in this population.
Statistical analysis:
The primary outcome is the difference in the self-reported ATRS score at 12 months in patients participating in the 8-weeks regime compared to the 11-week regime.
The sample size needed to detect a minimal clinical important difference of 10 points (SD 18) between the two groups is 102, with a significance level of 5% and a power of 80%. To allow for subgroup analysis and with an estimated rate of drop-out of 20%, a minimum of 200 patients will be included.
- Conditions
- Achilles Tendon Rupture, Achilles Tendon Injury
- Being tested
- 11 week restrictive regime, 8 week liberal regime
- Keywords
- Achilles tendon rupture, Functional ability, Immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11 week restrictive regimeOther
As part of standard care at AUH (until May 2024), patients are immobilized in scotch cast with the foot in plantarflexion during week 0-4. Next, the scotch cast is replaced by a ROM-WALKER in plantarflexion for the next 7 weeks (week 5-11 after injury). The ROM-WALKER is gradually corrected from 30 degrees plantarflexion to 0 degrees. No weight bearing or exercises is allowed and they are not allowed to remove the ROM-WALKER during week 0-10. At week 11, the patients are allowed weight bearing up to 30 kg, after which there is no longer weight bearing restrictions.
From week 12 they are allowed full weight bearing with a 1 cm heel lift i their shoes.
8 week liberal regimeOther
The patients are treated with a walker orthosis with 3 wedges in plantarflexion, during week 1-2 with no weight bearing and no exercises. After 2 weeks, the tendon will be examined, and if no defect in the tendon is detected by palpation, the patients will start partially weight bearing in week 3-5, and full weight-bearing week 6-8. They are instructed in unloaded exercises for the calf and anklejoint after 2 weeks, and loaded exercises (elastic) after 5 weeks, with a maximum position til 0 degrees in the anklejoint. Balancetraining and stationary bike training after 7 weeks. The wedges are removed one by one after 3, 5 and 7 weeks, respectively.
If there is a palpable defect in the tendon after 2 weeks, the patient must wait 1 week with partially weight bearing and exercises, and remove the wedges at 4, 5 and 7 weeks after the initiation of treatment.
From week 9, walking i their shoes with a 1 cm heel lift.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Achilles tendon rupture | Patients treated non-surgically at Aarhus University Hospital from 2022 to approximately 2028. Comparing an 8 week liberal regime wtih an 11 week restrictive regime. Receives: Other: 11 week restrictive regime; Other: 8 week liberal regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported ATRS score at 12 months after injury
Achilles tendon Total Rupture Score (ATRS) is a self-reported questionnaire with 10 items, summing up to a score of 0-100 points, with 100 points reflecting no disability. The primary outcome will be ATRS score at 12 months, but data will also be collected at 6 and 24 months to describe any changes over time.
Measured: 12 months post-injury
Secondary outcomes (3)
Percentage of participants with re-rupture at 12 months
Self-reported re-rupture with consisting information in the medical record.
Measured: 12 months post-injury
Percentage of participants who have returned to previous working status at 12 months
Self-reported return to previous work (if at working age)
Measured: 12 months post-injury
Extend of participants who have returned to sports activities at 24 months
Self-reported return to sports activities, on a 0-10 scale (worst-best)
Measured: 24 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Frank Fenger, Aarhus University Hospital
- Investigators
- Nanna Rolving, Ph.d., Study director, Aarhus University Hospital, Department of physiotherapy and occupational therapyPer Gundtoft, Ph.d., Study director, Aarhus University Hospital, Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614908
- Sponsor's protocol ID
- AarhusUH-MFenger
- Status last verified
- Sep 2024
- First submitted
- 3 Nov 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonsurgical Treatment of Achilles Tendon Rupture: Comparison of an 8-week Liberal Regime With an 11-week Restrictive Regime. A Prospective Cohort Quality Assurance Study.
- ClinicalTrials.gov ID
- NCT05614908
- Acronym / sponsor ID
- AarhusUH-MFenger
- Conditions
- Achilles Tendon Rupture, Achilles Tendon Injury
- Keywords
- Achilles tendon rupture, Functional ability, Immobilization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 14 Nov 2022 (actual)
- 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 main purpose of the study is to compare the patient-reported outcomes and adverse events of two different rehabilitation regimes for patients undergoing non-surgical treatment of Achilles Tendon Rupture. Thus, using a pre-post study design we will compare whether patients participating in an 8-week liberal rehabilitation regime will achieve the same, or better, self- reported functional ability, without increased risk of adverse events, in the first two years following injury, compared to an 11 weeks more restrictive rehabilitation regime..
Detailed description
Background:
The Achilles tendon is the most commonly injured tendon in the lower extremity, and can be treated either surgical or non-surgical. Previous studies have investigated early controlled motion and weight-bearing for non-surgically treated Achilles Tendon Rupture (ATR). Early motion may cause tendon elongation, which leads to decrease in push off strength, and thus potentially a poorer functional outcome. Conversely, delayed initiation of mobilisation and weight-bearing may similarly hinder or delay optimal recovery of function and return to work and sports. The correct treatment and rehabilitation, including the timing of rehabilitation initiation, may therefore be crucial to ensure the patients functional ability.
Most hospitals in Denmark treating patients with ATR, provide a regime of 8-9 weeks of treatment for non-surgically treated patients. At Aarhus University Hospital (AUH), however, a more restrictive regime has been provided for these patients in the past 7 years, with a treatment period of 11 weeks after injury, and with no or limited weight-bearing or exercises.
A previous retrospective study at AUH including 100 patients undergoing non-surgical treatment and the restrictive 11 week rehabilitation regime was conducted in 2023. The results documented a re-rupture rate of 4 %, comparable to the rate reported at the Danish ATR Database, and similarly comparable results on patient-reported disability measured with the Achilles tendon Total Rupture Score (ATRS). The Danish ATR Database includes data from 11 different hospitals in Denmark, where the majority have implemented a more liberal rehabilitation regime of 8-9 weeks of treatment with early weight-bearing and exercises. As a result of this retrospective study, we are changing the rehabilitation protocol of ATR at AUH, from 11 weeks restrictive regime, to an 8 weeks liberal regime.
Purpose:
With this quality assurance study we aim to compare patient-reported outcomes and adverse events in patients participating in an 8-week liberal regime compared to an 11-week restrictive regime following non-surgically treated ATR
Study design and setting:
This is an observational cohort study with prospectively collected patient-reported outcomes, conducted at AUH. First, 110 consecutive patients will be included while the existing 11-week restrictive regime is standard care, then the 8-week liberal regime will be implemented, and subsequently another 110 patients will be consecutively included.
Data collection procedures and outcomes:
Patients will receive a digital letter with a link to an online questionnaire to be completed at 6 months, 12 months and 24 months from the date of the treatment start.
Patients are asked to fill out the ATRS on functional ability, as well as additional questions regarding job status, return to sport, incidence of deep venous thrombosis, whether they have sustained a re-rupture, and their satisfaction with treatment they received at the hospital.
The ATRS is a 10-item questionnaire, with a score of 0 to 10 (worst-best), which has been found valid, reliable and responsive in this population.
Statistical analysis:
The primary outcome is the difference in the self-reported ATRS score at 12 months in patients participating in the 8-weeks regime compared to the 11-week regime.
The sample size needed to detect a minimal clinical important difference of 10 points (SD 18) between the two groups is 102, with a significance level of 5% and a power of 80%. To allow for subgroup analysis and with an estimated rate of drop-out of 20%, a minimum of 200 patients will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Achilles tendon rupture | – | Other: 11 week restrictive regime, Other: 8 week liberal regimePatients treated non-surgically at Aarhus University Hospital from 2022 to approximately 2028. Comparing an 8 week liberal regime wtih an 11 week restrictive regime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of approx. 220 consecutive acute achilles tendon rupture patients, treated non-surgically at Aarhus University Hospital from 2022 to approximately 2028.
Key inclusion criteria (4 listed)
- Patients with an acute achilles tendon rupture treated non-surgically at AUH
- Treatment start maximum 14 days after time of rupture
- ≥18 years
- Understand and read Danish
Key exclusion criteria (2 listed)
- Patients who have not followed the regime at AUH (e.g. terminated use of the ROM- walker prematurely or similar)
- Bilateral ATR or rupture of the opposite in the treatmentperiod
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 |
|---|---|---|
| 11 week restrictive regimeAs part of standard care at AUH (until May 2024), patients are immobilized in scotch cast with the foot in plantarflexion during week 0-4. Next, the scotch cast is replaced by a ROM-WALKER in plantarflexion for the next 7 weeks (week 5-11 after injury). The ROM-WALKER is gradually corrected from 30 degrees plantarflexion to 0 degrees. No weight bearing or exercises is allowed and they are not allowed to remove the ROM-WALKER during week 0-10. At week 11, the patients are allowed weight bearing up to 30 kg, after which there is no longer weight bearing restrictions. From week 12 they are allowed full weight bearing with a 1 cm heel lift i their shoes. | Other | Patients with Achilles tendon rupture |
| 8 week liberal regimeThe patients are treated with a walker orthosis with 3 wedges in plantarflexion, during week 1-2 with no weight bearing and no exercises. After 2 weeks, the tendon will be examined, and if no defect in the tendon is detected by palpation, the patients will start partially weight bearing in week 3-5, and full weight-bearing week 6-8. They are instructed in unloaded exercises for the calf and anklejoint after 2 weeks, and loaded exercises (elastic) after 5 weeks, with a maximum position til 0 degrees in the anklejoint. Balancetraining and stationary bike training after 7 weeks. The wedges are removed one by one after 3, 5 and 7 weeks, respectively. If there is a palpable defect in the tendon after 2 weeks, the patient must wait 1 week with partially weight bearing and exercises, and remove the wedges at 4, 5 and 7 weeks after the initiation of treatment. From week 9, walking i their shoes with a 1 cm heel lift. | Other | Patients with Achilles tendon rupture |
Primary outcome
Self-reported ATRS score at 12 months after injury
Time frame: 12 months post-injury
Achilles tendon Total Rupture Score (ATRS) is a self-reported questionnaire with 10 items, summing up to a score of 0-100 points, with 100 points reflecting no disability. The primary outcome will be ATRS score at 12 months, but data will also be collected at 6 and 24 months to describe any changes over time.
3 secondary outcomes
Percentage of participants with re-rupture at 12 months
Time frame: 12 months post-injury
Percentage of participants who have returned to previous working status at 12 months
Time frame: 12 months post-injury
Extend of participants who have returned to sports activities at 24 months
Time frame: 24 months post-injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Nanna Rolving, Ph.d. study director
Aarhus University Hospital, Department of physiotherapy and occupational therapy
Per Gundtoft, Ph.d. study director
Aarhus University Hospital, Department of Orthopaedics
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 Rupture and Achilles Tendon Injury, run by Aarhus 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 2 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: enrolling by invitation, as of the sponsor's last update on 20 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Self-reported ATRS score at 12 months after injury (time frame: 12 months post-injury). 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 20 Sep 2024.