Tendon InjuriesNCT02805751
Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures
A study testing Early loading on a training pedal, Tendon strain exercises and Early weight bearing in people with Tendon Injuries and Soft Tissue Injuries, run by Linkoeping University at 1 site in Sweden.
Trial summary
The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tendon Injuries, Soft Tissue Injuries, Achilles Tendon Rupture
- What is being tested?
- Early loading on a training pedal, Tendon strain exercises and Early weight bearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Nov 2019
- 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
- Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
- Presented within 14 days from injury
- 18-60 years old
Who cannot join
- Inability to understand swedish
- previous injured tendon
- Diabetes mellitus
- History of Rheumatoid disease
- Treatment with steroids
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University Hospital Linkoeping
Linköping, Östergötland County, 58729
About this study
Official title: Mechanical Properties in Conservative Treated Achilles Tendon Ruptures With or Without Early Controlled Loading
The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA).
The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.
Read the detailed description
Treatment of Achilles tendon ruptures includes surgical repair or immobilization in an orthosis, followed by prolonged rehabilitation. Improved rehabilitation regimens still display imperfect recovery, with deficits such as persistent end-range muscle weakness, tendon elongation and incomplete return to pre-injury activity level. The underlying mechanisms are unknown, but are likely to involve molecular and cellular aspects of the early healing processes. Animal experiments have shown that short episodes of vigorous loading during tendon healing create a stronger tendon, and lead to less elongation than continuous loading. Early controlled training has also been shown to improve the material properties of surgically repaired tendons. However, more and more clinics now turn away from surgery and towards conservative treatment, while studies on rehabilitation mainly concern sutured tendons. It is therefore also important to understand how to best rehabilitate conservatively treated patients. The aim is to investigate the effect of early controlled loading on conservatively treated Achilles tendon ruptures.
The patients (age 18-60 years of age) are treated conservatively by receiving a removable foam walker boot at the emergency department. The patients are thereafter called by the principal investigator and are asked if they want to participate in the study. Patients who are interested in participating in the study receive oral and in written information about the study of the principal investigator of the study (Pernilla Eliasson).
After 2 weeks, the rupture is localized by ultrasound and 4 tantalum beads are implanted percutaneously in the proximal and distal part of the tendon. These beads are used for measurements of the mechanical properties of the tendon by using RSA.
The patients are thereafter randomized to early controlled loading or control.
All patients wear the foam walker boot for 7 weeks. Full weight-bearing is allowed as tolerated from the beginning. Both groups perform motion exercises outside the boot with 20 repetitions, 3 times per day as of 14 days after rupture.
The patients in the early loading group are provided with a special training pedal where pedal resistance can be increased during the treatment period. The patients will use this pedal twice a day starting 2 weeks after rupture.
After the initial 7 weeks, the patients are referred to physical therapists uninvolved in this research, but with the instruction to follow the regional rehabilitation guidelines for Achilles tendon ruptures.
Mechanical properties of the tendon will be estimated by measuring tendon length, cross-sectional area (CSA) and stiffness at week 7, 19 and 52.
The elastic modulus of the tendon at 19 weeks it the primary variable of this study.
At week 7, both the elastic and plastic deformation will be measured. Tendon CSA will be evaluated using computer tomography (CT). Tendon elongation will be evaluated by RSA at week 2, 7, 19 and 52. Calf muscle circumference, passive and active range of motion in the ankle joint and a heel-raise test will be performed at week 19 and 52.
The overall function will be assessed by the Achilles Tendon Rupture Score at 19 and 52 weeks.
Complications and re-ruptures will be registered.
- Being tested
- Early loading on a training pedal, Tendon strain exercises, Early weight bearing
- Keywords
- Achilles, Tendon, Loading, Rehabilitation
- Medical subject headings
- Tendon Injuries, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early loading on a training pedalDevice
The patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal.
Tendon strain exercisesOther
The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.
Early weight bearingOther
The patients are allowed to bear weight as much as tolerated in the walker from day 1.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This constitutes the currently accepted regime and is therefore consider the control group (CTRL) with early range of motion and early weight bearing. The control group was allowed to have weight-bearing as tolerated from day 0. They are also instructed to perform tendon strain exercises 3 times each day from 2 weeks after the rupture. Receives: Other: Tendon strain exercises; Other: Early weight bearing |
| Early loading | Experimental | The patients in the early loading group are also allowed to have weight-bearing as tolerated from day 0 and perform tendon strain exercises 3 times each day from 2 weeks after the rupture. The patients in this group will also remove the walker twice a day and use a special training pedal for 5 weeks (until walker removal). Receives: Device: Early loading on a training pedal; Other: Tendon strain exercises; Other: Early weight bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulus of Elasticity
Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.
Measured: 19 weeks
Secondary outcomes (7)
Tendon elongation
Tendon elongation will be evaluated using RSA and measurements of the distance between tantalum beads
Measured: 2, 7, 19 and 52 weeks after rupture
Modulus of Elasticity
Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.
Measured: 7 and 52 weeks after rupture
Achilles tendon total rupture score (ATRS)
Patient reported outcome regarding function in their Achilles tendon
Measured: 19 and 52 weeks after rupture
Maximal range of motion
The maximun range of motion in the ankle joint will be measured in plantar and dorsiflexion.
Measured: 19 and 52 weeks after rupture
Heel-rise
The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.
Measured: 19 and 52 weeks after rupture
Plastic deformation of the tendon
Plastic deformation will be measured using RSA and measurements of the distance between tantalum beads while the patient continues to have a load on the tendon for 3 minutes with a weight. Tendon size will be measured using CT.
Measured: 7 weeks after rupture
Calf muscle circumference
Measurement of the circumference at the thickest part of the calf
Measured: 19 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionNov 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tendon InjuriesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- University Hospital, Linkoeping
- Responsible party
- Principal investigator, Pernilla Eliasson, Linkoeping University
- Investigators
- Per Aspenberg, MD, PhD, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805751
- Sponsor's protocol ID
- Early loading
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2016
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rendek Z, Bon Beckman L, Schepull T, Danmark I, Aspenberg P, Schilcher J, Eliasson P. Early Tensile Loading in Nonsurgically Treated Achilles Tendon Ruptures Leads to a Larger Tendon Callus and a Lower Elastic Modulus: A Randomized Controlled Trial. Am J Sports Med. 2022 Oct;50(12):3286-3298. doi: 10.1177/03635465221117780. Epub 2022 Aug 25.
PubMed 36005394
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Properties in Conservative Treated Achilles Tendon Ruptures With or Without Early Controlled Loading
- ClinicalTrials.gov ID
- NCT02805751
- Acronym / sponsor ID
- Early loading
- Keywords
- Achilles, Tendon, Loading, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- University Hospital, Linkoeping
- Study start
- Oct 2015
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 20 Jun 2016 (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 purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA).
The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.
Detailed description
Treatment of Achilles tendon ruptures includes surgical repair or immobilization in an orthosis, followed by prolonged rehabilitation. Improved rehabilitation regimens still display imperfect recovery, with deficits such as persistent end-range muscle weakness, tendon elongation and incomplete return to pre-injury activity level. The underlying mechanisms are unknown, but are likely to involve molecular and cellular aspects of the early healing processes. Animal experiments have shown that short episodes of vigorous loading during tendon healing create a stronger tendon, and lead to less elongation than continuous loading. Early controlled training has also been shown to improve the material properties of surgically repaired tendons. However, more and more clinics now turn away from surgery and towards conservative treatment, while studies on rehabilitation mainly concern sutured tendons. It is therefore also important to understand how to best rehabilitate conservatively treated patients. The aim is to investigate the effect of early controlled loading on conservatively treated Achilles tendon ruptures.
The patients (age 18-60 years of age) are treated conservatively by receiving a removable foam walker boot at the emergency department. The patients are thereafter called by the principal investigator and are asked if they want to participate in the study. Patients who are interested in participating in the study receive oral and in written information about the study of the principal investigator of the study (Pernilla Eliasson).
After 2 weeks, the rupture is localized by ultrasound and 4 tantalum beads are implanted percutaneously in the proximal and distal part of the tendon. These beads are used for measurements of the mechanical properties of the tendon by using RSA.
The patients are thereafter randomized to early controlled loading or control.
All patients wear the foam walker boot for 7 weeks. Full weight-bearing is allowed as tolerated from the beginning. Both groups perform motion exercises outside the boot with 20 repetitions, 3 times per day as of 14 days after rupture.
The patients in the early loading group are provided with a special training pedal where pedal resistance can be increased during the treatment period. The patients will use this pedal twice a day starting 2 weeks after rupture.
After the initial 7 weeks, the patients are referred to physical therapists uninvolved in this research, but with the instruction to follow the regional rehabilitation guidelines for Achilles tendon ruptures.
Mechanical properties of the tendon will be estimated by measuring tendon length, cross-sectional area (CSA) and stiffness at week 7, 19 and 52.
The elastic modulus of the tendon at 19 weeks it the primary variable of this study.
At week 7, both the elastic and plastic deformation will be measured. Tendon CSA will be evaluated using computer tomography (CT). Tendon elongation will be evaluated by RSA at week 2, 7, 19 and 52. Calf muscle circumference, passive and active range of motion in the ankle joint and a heel-raise test will be performed at week 19 and 52.
The overall function will be assessed by the Achilles Tendon Rupture Score at 19 and 52 weeks.
Complications and re-ruptures will be registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Tendon strain exercises, Other: Early weight bearingThis constitutes the currently accepted regime and is therefore consider the control group (CTRL) with early range of motion and early weight bearing. The control group was allowed to have weight-bearing as tolerated from day 0. They are also instructed to perform tendon strain exercises 3 times each day from 2 weeks after the rupture. |
| Early loading | Experimental | Device: Early loading on a training pedal, Other: Tendon strain exercises, Other: Early weight bearingThe patients in the early loading group are also allowed to have weight-bearing as tolerated from day 0 and perform tendon strain exercises 3 times each day from 2 weeks after the rupture. The patients in this group will also remove the walker twice a day and use a special training pedal for 5 weeks (until walker removal). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
- Presented within 14 days from injury
- 18-60 years old
Key exclusion criteria (5 listed)
- Inability to understand swedish
- previous injured tendon
- Diabetes mellitus
- History of Rheumatoid disease
- Treatment with steroids
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 |
|---|---|---|
| Early loading on a training pedalThe patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal. | Device | Early loading |
| Tendon strain exercisesThe patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture. | Other | Control, Early loading |
| Early weight bearingThe patients are allowed to bear weight as much as tolerated in the walker from day 1. | Other | Control, Early loading |
Primary outcome
Modulus of Elasticity
Time frame: 19 weeks
Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.
7 secondary outcomes
Tendon elongation
Time frame: 2, 7, 19 and 52 weeks after rupture
Modulus of Elasticity
Time frame: 7 and 52 weeks after rupture
Achilles tendon total rupture score (ATRS)
Time frame: 19 and 52 weeks after rupture
Maximal range of motion
Time frame: 19 and 52 weeks after rupture
Heel-rise
Time frame: 19 and 52 weeks after rupture
Plastic deformation of the tendon
Time frame: 7 weeks after rupture
Calf muscle circumference
Time frame: 19 and 52 weeks
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 Aug 2021.
- Derived from this study: PubMed 36005394Rendek Z, Bon Beckman L, Schepull T, Danmark I, Aspenberg P, Schilcher J, Eliasson P. Early Tensile Loading in Nonsurgically Treated Achilles Tendon Ruptures Leads to a Larger Tendon Callus and a Lower Elastic Modulus: A Randomized Controlled Trial. Am J Sports Med. 2022 Oct;50(12):3286-3298. doi: 10.1177/03635465221117780. Epub 2022 Aug 25.
- Individual participant dataSharing planned: No
Related trials for Tendon Injuries
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
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.
Per Aspenberg, MD, PhD study director
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early loading on a training pedal, Tendon strain exercises and Early weight bearing in people with Tendon Injuries and Soft Tissue Injuries, run by Linkoeping University at 1 site in Sweden.
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 5 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 Aug 2021. 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 Sweden. 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?
Modulus of Elasticity (time frame: 19 weeks). 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 NCT02805751, which also lists 1 linked publication.
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 Aug 2021.