Achilles Tendon RuptureNCT03543943
Achilles Tendon Elongation and Gait Pattern After Rupture.
A study testing Individualized treatment of Acute Achilles tendon rupture., Non-operative treatment and Operative treatment in people with Achilles Tendon Rupture, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The objective of this study is to determine if Achilles tendon elongation and gait pattern differ between patients treated using an individualized treatment algorithm and patients treated as usual (two control groups; patients treated operatively and non-operatively). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Individualized treatment of Acute Achilles tendon rupture., Non-operative treatment and Operative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jun 2018to 10 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Appointment in the Outpatients Department within 4 days of injury.
- Total Achilles tendon rupture.
- Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
- The patient must be expected to be able to attend rehabilitation and postexamination.
- The patient must be able to speak and understand Danish.
- The patient must be able to give informed consent.
Who cannot join
- Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
- Previous rupture of the Achilles tendon in any of the two legs.
- Treated with fluoroquinolones or corticosteroids within the last 6 months.
- In medical treatment of diabetes.
- Suffers from rheumatic disease.
- Other conditions prior to the injury resulting in reduced function of any of the two legs.
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- Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
- Inability to lie in prone position on the operating table.
- Terminal illness or severe medical illness: American Society of Anaesthesiologists physical status classification score higher than or equal to 3.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physiotherapy and Orthopedical surgery, Copenhagen University Hospital, Amager-Hvidovre
Copenhagen, Hvidovre, DK-2650
About this study
Official title: Achilles Tendon Elongation and Gait Pattern After Rupture: A Three Armed Randomized Controlled Trial Comparing an Individualized Treatment Algorithm vs. Operative or Non-operative Treatment.
The objective of this study is to determine if Achilles tendon elongation and gait pattern differ between patients treated using an individualized treatment algorithm and patients treated as usual (two control groups; patients treated operatively and non-operatively).
The individualized treatment algorithm is based on ultrasonographic status of tendon overlap and Copenhagen Achilles Length Measure (1). Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Individualized treatment of Acute Achilles tendon rupture., Non-operative treatment, Operative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized treatment of Acute Achilles tendon rupture.Procedure or surgery
The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon [1]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively.
Non-operative treatmentProcedure or surgery
Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
Operative treatmentProcedure or surgery
Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
| Study group | Role | What they receive |
|---|---|---|
| Individualized treatment | Experimental | The ruptured achilles tendon is examined by ultrasonography. If the overlap of the tendon ends is less than 25 % or the tendon is elongated 7 % or more the patient receives conventional open operative treatment. The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast after surgery. The ankle is held at maximal plantar flexion. Weight bearing is not allowed. After 3 weeks the cast is removed and the injured leg is transferred to a functional brace with 3 heel wedges. The patient will follow standard functional rehabilitation and the follow-up evaluations. Receives: Procedure: Individualized treatment of Acute Achilles tendon rupture. |
| Control group 1 | Active comparator | For the patients allocated to non-operative treatment the injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations. Receives: Procedure: Non-operative treatment |
| Control group 2 | Active comparator | The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations. Receives: Procedure: Operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-Dimensional Gait Analysis: Ankle peak power during push-off.
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Measured: 12 months after started treatment.
Secondary outcomes (7)
Copenhagen Achilles Length Measure
The examination of both the total and the free part of the achilles tendon of both the injured and un-injured leg is performed. The total length of the tendon is defined under the description of the intervention. The free part of the achilles tendon is defined as the distance between the proximal border of calcaneus and the musculotendinous junction of the soleus muscle and the achilles tendon. The method will be used both diagnostically for the individualized treatment and as a secondary endpoint.
Measured: 6 and 12 months after started treatment.
Three-Dimensional Gait Analysis: Ankle peak power during push-off
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Measured: 6 months after started treatment.
Three-Dimensional Gait Analysis: Maximal dorsiflexion in the stance phase.
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Measured: 6 and 12 months after started treatment.
Three-Dimensional Gait Analysis: stiffness of the plantar flexor musculo-tendinous complex during dorsiflexion.
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Measured: 6 and 12 months after started treatment.
Three-Dimensional Gait Analysis: time of heel-lift
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Measured: 6 and 12 months after started treatment.
Three-Dimensional Gait Analysis: jumping up and down
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Measured: 6 and 12 months after started treatment.
Balance measurement
The postural sway with patient standing on a force plate in the gait laboratory.
Measured: 6 and 12 months after started treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start4 Jun 2018
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Swennergren Hansen, Hvidovre University Hospital
- Investigators
- Maria S Hansen, PT, MSc, Principal investigator, Copenhagen University Hospital, Amager-Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543943
- Sponsor's protocol ID
- Achilles HVH RCT
- Status last verified
- Mar 2022
- First submitted
- 3 May 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan of sharing data with researchers not already included in this study.
Publications
Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Dossing S, Troelsen A. Validation of a novel ultrasound measurement of achilles tendon length. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3398-406. doi: 10.1007/s00167-014-3175-2. Epub 2014 Jul 20.
PubMed 25038882
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achilles Tendon Elongation and Gait Pattern After Rupture: A Three Armed Randomized Controlled Trial Comparing an Individualized Treatment Algorithm vs. Operative or Non-operative Treatment.
- ClinicalTrials.gov ID
- NCT03543943
- Acronym / sponsor ID
- Achilles HVH RCT
- Conditions
- Achilles Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 1 Jun 2018 (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 objective of this study is to determine if Achilles tendon elongation and gait pattern differ between patients treated using an individualized treatment algorithm and patients treated as usual (two control groups; patients treated operatively and non-operatively).
The individualized treatment algorithm is based on ultrasonographic status of tendon overlap and Copenhagen Achilles Length Measure (1). Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized treatment | Experimental | Procedure: Individualized treatment of Acute Achilles tendon rupture.The ruptured achilles tendon is examined by ultrasonography. If the overlap of the tendon ends is less than 25 % or the tendon is elongated 7 % or more the patient receives conventional open operative treatment. The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast after surgery. The ankle is held at maximal plantar flexion. Weight bearing is not allowed. After 3 weeks the cast is removed and the injured leg is transferred to a functional brace with 3 heel wedges. The patient will follow standard functional rehabilitation and the follow-up evaluations. |
| Control group 1 | Active comparator | Procedure: Non-operative treatmentFor the patients allocated to non-operative treatment the injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations. |
| Control group 2 | Active comparator | Procedure: Operative treatmentThe tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Appointment in the Outpatients Department within 4 days of injury.
- Total Achilles tendon rupture.
- Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
- The patient must be expected to be able to attend rehabilitation and postexamination.
- The patient must be able to speak and understand Danish.
Key exclusion criteria (9 listed)
- Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
- Previous rupture of the Achilles tendon in any of the two legs.
- Treated with fluoroquinolones or corticosteroids within the last 6 months.
- In medical treatment of diabetes.
- Suffers from rheumatic disease.
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 |
|---|---|---|
| Individualized treatment of Acute Achilles tendon rupture.The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon [1]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively. | Procedure or surgery | Individualized treatment |
| Non-operative treatmentCirculated cast below the knee in maximal, unforced plantar flexion over the ankel. | Procedure or surgery | Control group 1 |
| Operative treatmentOpen surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel. | Procedure or surgery | Control group 2 |
Primary outcome
Three-Dimensional Gait Analysis: Ankle peak power during push-off.
Time frame: 12 months after started treatment.
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
7 secondary outcomes
Copenhagen Achilles Length Measure
Time frame: 6 and 12 months after started treatment.
Three-Dimensional Gait Analysis: Ankle peak power during push-off
Time frame: 6 months after started treatment.
Three-Dimensional Gait Analysis: Maximal dorsiflexion in the stance phase.
Time frame: 6 and 12 months after started treatment.
Three-Dimensional Gait Analysis: stiffness of the plantar flexor musculo-tendinous complex during dorsiflexion.
Time frame: 6 and 12 months after started treatment.
Three-Dimensional Gait Analysis: time of heel-lift
Time frame: 6 and 12 months after started treatment.
Three-Dimensional Gait Analysis: jumping up and down
Time frame: 6 and 12 months after started treatment.
Balance measurement
Time frame: 6 and 12 months after started treatment.
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 16 Mar 2022.
- Background: PubMed 25038882Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Dossing S, Troelsen A. Validation of a novel ultrasound measurement of achilles tendon length. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3398-406. doi: 10.1007/s00167-014-3175-2. Epub 2014 Jul 20.
- Individual participant dataSharing planned: No. There is no plan of sharing data with researchers not already included in this study.
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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.
Maria S Hansen, PT, MSc principal investigator
Copenhagen University Hospital, Amager-Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized treatment of Acute Achilles tendon rupture., Non-operative treatment and Operative treatment in people with Achilles Tendon 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 6 inclusion and 9 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 16 Mar 2022. 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?
Three-Dimensional Gait Analysis: Ankle peak power during push-off. (time frame: 12 months after started treatment.). 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 NCT03543943, 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 16 Mar 2022.