Achilles Tendon RuptureDELOATNCT04263493
Delayed Loading Following Repair of a Ruptured Achilles Tendon
A study testing Rehabilitation (physiotheraphy) in people with Achilles Tendon Rupture, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Rehabilitation (physiotheraphy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 20 May 2020to 1 Oct 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with a traumatic, complete mid-substance Achilles tendon
- No contraindications for MRI
- Presented within 14 days from injury
- Adult (18 to 60 years)
- Understand Danish
- Manage transport to/from the hospital on their own
Who cannot join
- Other injuries affecting their lower limb functions
- Prior Achilles tendon Rupture
- Smoking
- Systemic diseases influencing tendon healing
- Anticoagulation treatment
- Inability to follow rehabilitation or complete follow-ups
- Immunosuppressive treatment including systematic corticosteroid treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial
The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year.
The investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).
- Conditions
- Achilles Tendon Rupture
- Being tested
- Rehabilitation (physiotheraphy)
- Keywords
- Achilles Tendon Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation (physiotheraphy)Other
Time of loading, range of motion exercises, strength training
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization (loading) | Active comparator | This constitutes the currently accepted regime and is therefore considered the control group.
Cast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3 Receives: Other: Rehabilitation (physiotheraphy) |
| Delayed mobilization (loading) | Experimental | Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3 Receives: Other: Rehabilitation (physiotheraphy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heel-rise test
Heel-rise height deficit on the injured side relative to the uninjured side
Measured: One-year follow-up
Secondary outcomes (7)
Tendon length and cross-sectional area
MRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion.
Measured: 1 week, 3 months, 6 months and 1 year
The Achilles tendon rupture score (ATRS)
The Achilles tendon rupture score questionnaire is a patient-reported outcome with a possible score from 1-100, where higher scores mean a better outcome.
Measured: Recall before injury and 1 year
Muscle fascicle length and doppler activity in the tendon
Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography
Measured: 2 weeks, 3 months, 6 months and 1 year
Isokinetic plantar flexion muscle strength
The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.
Measured: 1 year
Physical activity level
A questionnaire is used to measure the physical activity level (including type of activity) of the participants.
Measured: Recall before injury and 1 year
Heel-rise work
An instrumented heel-rise test will be conducted to measure work capacity
Measured: 6 months and 1 year
The Achilles tendon resting angle (ATRA)
Achilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended.
Measured: 2 weeks, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start20 May 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Høffner, Bispebjerg Hospital
- Investigators
- Peter Magnusson, Professor, Principal investigator, Institute of Sportsmedicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263493
- Sponsor's protocol ID
- 01012020
- Acronym
- DELOAT
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoeffner R, Svensson RB, Gillani SZ, Linden FH, Magnusson SP. Morphological Changes One Year After Achilles Tendon Rupture Repair: A Comparison of Loading Strategies. Transl Sports Med. 2025 Sep 28;2025:1778630. doi: 10.1155/tsm2/1778630. eCollection 2025.
PubMed 41059465Hoeffner R, Agergaard AS, Svensson RB, Cullum C, Mikkelsen RK, Konradsen L, Krogsgaard M, Boesen M, Kjaer M, Magnusson SP. Tendon Elongation and Function After Delayed or Standard Loading of Surgically Repaired Achilles Tendon Ruptures: A Randomized Controlled Trial. Am J Sports Med. 2024 Mar;52(4):1022-1031. doi: 10.1177/03635465241227178. Epub 2024 Feb 14.
PubMed 38353060
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04263493
- Acronym / sponsor ID
- DELOAT / 01012020
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles Tendon Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 10 Feb 2020 (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 purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year.
The investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobilization (loading) | Active comparator | Other: Rehabilitation (physiotheraphy)This constitutes the currently accepted regime and is therefore considered the control group. Cast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3 |
| Delayed mobilization (loading) | Experimental | Other: Rehabilitation (physiotheraphy)Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed with a traumatic, complete mid-substance Achilles tendon
- No contraindications for MRI
- Presented within 14 days from injury
- Adult (18 to 60 years)
- Understand Danish
Key exclusion criteria (7 listed)
- Other injuries affecting their lower limb functions
- Prior Achilles tendon Rupture
- Smoking
- Systemic diseases influencing tendon healing
- Anticoagulation treatment
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 |
|---|---|---|
| Rehabilitation (physiotheraphy)Time of loading, range of motion exercises, strength training | Other | Delayed mobilization (loading), Early mobilization (loading) |
Primary outcome
Heel-rise test
Time frame: One-year follow-up
Heel-rise height deficit on the injured side relative to the uninjured side
7 secondary outcomes
Tendon length and cross-sectional area
Time frame: 1 week, 3 months, 6 months and 1 year
The Achilles tendon rupture score (ATRS)
Time frame: Recall before injury and 1 year
Muscle fascicle length and doppler activity in the tendon
Time frame: 2 weeks, 3 months, 6 months and 1 year
Isokinetic plantar flexion muscle strength
Time frame: 1 year
Physical activity level
Time frame: Recall before injury and 1 year
Heel-rise work
Time frame: 6 months and 1 year
The Achilles tendon resting angle (ATRA)
Time frame: 2 weeks, 3 months, 6 months and 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 10 Feb 2023.
- Derived from this study: PubMed 41059465Hoeffner R, Svensson RB, Gillani SZ, Linden FH, Magnusson SP. Morphological Changes One Year After Achilles Tendon Rupture Repair: A Comparison of Loading Strategies. Transl Sports Med. 2025 Sep 28;2025:1778630. doi: 10.1155/tsm2/1778630. eCollection 2025.
- Derived from this study: PubMed 38353060Hoeffner R, Agergaard AS, Svensson RB, Cullum C, Mikkelsen RK, Konradsen L, Krogsgaard M, Boesen M, Kjaer M, Magnusson SP. Tendon Elongation and Function After Delayed or Standard Loading of Surgically Repaired Achilles Tendon Ruptures: A Randomized Controlled Trial. Am J Sports Med. 2024 Mar;52(4):1022-1031. doi: 10.1177/03635465241227178. Epub 2024 Feb 14.
- 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. This study is not recruiting at the moment.
Peter Magnusson, Professor principal investigator
Institute of Sportsmedicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation (physiotheraphy) in people with Achilles Tendon Rupture, run by Bispebjerg 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 6 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 10 Feb 2023. 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?
Heel-rise test (time frame: One-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263493, which also lists 2 linked publications.
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 10 Feb 2023.