Achilles Tendon RuptureEarlyM-AchilNCT02318472
Early Mobilization After Achilles Tendon Rupture
A study testing VACOped orthosis and Plaster cast in people with Achilles Tendon Rupture and Deep Venous Thrombosis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether early mobilization after Achilles tendon rupture can speed up healing, prevent development of venous thromboembolism and improve patient outcome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Achilles Tendon Rupture, Deep Venous Thrombosis
- What is being tested?
- VACOped orthosis and Plaster cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute unilateral ATR, operated on within 96 hours
- Age between 18 and 75 years
Who cannot join
- Inability to give informed consent
- Current anticoagulation treatment (including high dose acetylsalicylic acid)
- Planned follow-up at other hospital
- Inability to follow instructions
- Known kidney failure
- Heart failure with pitting oedema
Show all 11Show fewer
- Thrombophlebitis
- Thromboembolic event during the previous three months
- Other surgery during the previous month
- Known malignancy
- Haemophilia; and pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Direct Functional Mobilization After Achilles Tendon Rupture on Healing and Outcome
The purpose of this study is to determine whether early mobilization after Achilles tendon rupture can speed up healing, prevent development of venous thromboembolism and improve patient outcome.
Read the detailed description
Patients with acute Achilles tendon rupture will be screened for eligibility at the Karolinska University Hospital and Södersjukhuset, Stockholm.
One hundred-fifty patients will be included and enrolled and assigned to the interventions either by a third party nurse or by a research nurse. Randomisation will be performed with use of computer-generated random numbers in permuted blocks of four, through an independent software specialist, and consecutively numbered, sealed, opaque envelopes opened after surgery and prior to treatment.
The patients will be randomized to undergo either treatment as usual using plaster cast treatment alone or direct post-operative functional mobilization with a weight-bearing orthosis with adjustable range of motion of the ankle.
The power calculation was based upon data from a recent study reporting a 50% rate of CDU-verified DVT after ATR surgery (Domeij-Arverud et a. 2015). We estimated early functional mobilization (EFM) to confer a 50% risk reduction. Sixty-three patients in each group were required to detect a difference of 25% in the incidence of DVT (two-sided type-I error rate = 5%; power = 80%). We decided to include 150 patients to counteract drop-outs. On recommendations from the ethical committee, a ratio of 2:1 was chosen, since our hypothesis was that the EFM group would perform better.
The endpoint of the first part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair. The sample size for the outcome in the microdialysis study was calculated on a difference of the glutamate metabolite of 12 µM between the two groups. For this power analysis, we used a glutamate standard difference of 15 µM resulting from a previous study. It was determined that a sample size of 25 patients per group would be necessary to detect the glutamate difference with 80% power when alpha was set equal to 5%. Anticipating that we would lose 10% of participants enrolled, we plan to enroll 27 patients in each group for microdialysis.
The primary aim of the short-term follow up of this randomized, controlled trial was to assess the efficacy of EFM to reduce the DVT incidence after ATR surgery, at two and six weeks post-operatively, compared to treatment-as-usual, i.e. two weeks of plaster cast followed by four weeks' orthosis immobilization. The secondary aim was to evaluate the effect of patient intrinsic factors (age, BMI, calf circumference, ankle range of motion, pain and fear of movement) and patient extrinsic factors (amount of weightbearing, number of daily steps) on the risk of sustaining a DVT.
The primary aim with the long-term follow up is to investigate the effect of early postoperative functional mobilization compared to immobilization on patient-reported function, health, fear of movement, physical activity level, and differences in functional capacity. The second aim is to explore if the occurrence of DVT postoperatively effects functional outcome in the long-term after surgical treatment of ATR.
Additional aims:
The primary aim of the second part of this study was to assess the number of steps and the amount of loading in a weight bearing orthosis during the first six weeks post-surgical ATR repair. A secondary purpose was to investigate if the amount of loading was correlated to fear of movement or/and pain.
The aim with this substudy is to describe differences between the two groups over time regarding tendon elongation, differences in muscle cross-sectional area and differences in tendon cross-sectional area (on the injured side) and to examine if the differences can predict functional outcome in the long-term and if any of the follow-up occasions are most important for long-term functional outcome.
Few studies have evaluated outcome more than one year after injury. The aim of this substudy is to investigate differences in outcome at 3 years after injury between the patients that sustained a DVT and those who did not sustain a DVT. Another aim is to compare the two intervention groups over 3-years time.
- Conditions
- Achilles Tendon Rupture, Deep Venous Thrombosis
- Being tested
- VACOped orthosis, Plaster cast
- Keywords
- Microdialysis, Patient related outcome, Heel rise test, Immobilization, functional mobilization, Ultrasound
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VACOped orthosisDevice
Weight-bearing orthosis with adjustable range of motion of the ankle
Plaster castDevice
Lower limb plaster cast
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization | Experimental | Functional mobilization initiated directly post-operative with a weight-bearing VACOped orthosis with adjustable range of motion of the ankle Receives: Device: VACOped orthosis |
| Immobilization | Active comparator | Treatment as usual using plaster cast immobilization Receives: Device: Plaster cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep venous thrombosis (DVT)
At 2 and 6 weeks postoperatively the number of participants with DVT will be assessed by compression duplex ultrasound (CDU)
Measured: Six weeks
Secondary outcomes (19)
Functional outcome - muscular endurance tests (heel-rise)
The functional outcome will be assessed at 26 and 52 weeks and 3-4 years postoperatively by validated muscular endurance test, i.e. heel rise test.
Measured: Four years
Patient-reported outcome - ATRS
The patients' symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS). 6, 12 months and 3-4 years postoperatively
Measured: Four years
Patient-reported outcome - EQ-5D
The patients' symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D).
Measured: One year
Physical activity - PAS
The patients' physical activity levels will be assessed a valid score; the Physical Activity scale (PAS). 6, 12 months and 3-4 years postoperatively
Measured: Four years
Patient-reported outcome - The Foot and Ankle Outcome Score (FAOS)
The patients' symptoms will be assessed using the reliable and valid score; The Foot and Ankle Outcome Score. FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Functioning sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). Each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Assessed 6 and 12 months postoperatively
Measured: One year
Patient-reported outcome - RAND 36 Health and Quality of Life questionnaire
The patients' symptoms will be assessed using the reliable and valid score; The RAND-36 Health and Quality of Life. The questionnaire is composed of 36 items, scored from 1 to 2,3, 5 or 6, some items are scored reversed. The score is divided in 8 subscales (dimensions) as the SF-36 questionnarie. The software recodes the points to a scale of 0 (worst) to 100 (best) for each subscale. Assessed at 6 and 12 months postoperatively
Measured: One year
Patient-reported outcome - Tampa Scale of Kinesiophobia, Swedish version, TSK-SV
The patients' symptoms will be assessed using the reliable and valid score; The Tampa Scale of Kinesiophobia-SV. The scale comprises of 17 items and a total score is computed. 4 items are inverted and rescaled Before summation. Each item are scored from 1 (strongly disagree) to 4 (strongly agree). The total sum is between 17 to 68, where a score of more than 37 is defined as kinesiophobia. Assessed at 2 and 6 weeks and 6 and 12 months postoperatively
Measured: One year
Plantar force loading
Measured with mobile force sensors, insoles at 2 and 6 weeks postoperatively
Measured: Six weeks
Patient-reported diary - self-reported loading
Estimation on daily self-reported loading on a VAS-scale, scored from 0 (non-weightbearing) to 100 (full weightbearing). Performed at home during the first 2 weeks postoperatively. The VAS scale is converted to percent (%) for analysis.
Measured: Two weeks
Patient-reported diary - pain ratings
Pain ratings on a VAS-scale at home during the first week postoperatively. The patients are rating their pain from 0 (no pain) to 100 (worst imaginable pain) during activity and at rest.
Measured: Two weeks
Patient-reported diary - steps/day
Measurement of number of steps taken each day with a valid pedometer at home during the first 2 weeks postoperatively
Measured: Two weeks
Calf circumference
Measured with a tape measure at the thickest part of the calf in sitting position at 2 and 6 weeks and 6, 12 months and 3-4 years postoperatively
Measured: Four years
Ankle dorsiflexion
Ankle range of motion in dorsiflexion, measured in sitting position with goniometer at 2 and 6 weeks postoperatively
Measured: Six weeks
Tendon length measurement
Ultrasound measurement on Achilles tendon length, measured in centimeters, from the calcaneal bone to the gastrocnemius and the soleus muscles, with extended field-of-view images. Images taken at 2 and 6 weeks and 6 and 12 months and 3-4 years postoperatively
Measured: Four years
Tendon thickness measurement
Ultrasound measurement on Achilles tendon circumference (thickness), measured in cm2, with B-mode images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively
Measured: One year
Muscle volume of the calf muscles
Ultrasound measurement on muscle volume of the calf muscles (gastrocnemius), measured in cm2, with extended field-of-view images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively
Measured: One year
Thickness of the calf muscles
Ultrasound measurement on thickness of the calf muscle (soleus). Measured in centimeter, with B-mode images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively
Measured: One year
Achilles Tendon resting angle (ATRA)
A clinical measurement of indirect Tendon length with patient prone lying, measured with goniometer with arms parallell to fibula and MTP5, measured at 2 and 6 weeks and 6 and 12 months and 3-4 years postoperatively
Measured: Four years
3D gait analysis
Three-dimensional gait analysis, performed at 8 weeks and 6 months postoperatively, measurement of the quality of gait
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2019
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- OPED GmbH
- Responsible party
- Principal investigator, Paul Ackermann, Karolinska University Hospital
- Investigators
- Paul W Ackermann, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318472
- Sponsor's protocol ID
- VR2012-2510
- Acronym
- EarlyM-Achil
- Status last verified
- Mar 2024
- First submitted
- 9 Dec 2014
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Saarensilta A, Aufwerber S, Gravare Silbernagel K, Ackermann P. Early Tendon Morphology as a Biomarker of Long-term Patient Outcomes After Surgical Repair of Achilles Tendon Rupture: A Prospective Cohort Study. Orthop J Sports Med. 2023 Nov 6;11(11):23259671231205326. doi: 10.1177/23259671231205326. eCollection 2023 Nov.
PubMed 37941888Chen J, Wang J, Hart DA, Zhou Z, Ackermann PW, Ahmed AS. Complement factor D regulates collagen type I expression and fibroblast migration to enhance human tendon repair and healing outcomes. Front Immunol. 2023 Sep 6;14:1225957. doi: 10.3389/fimmu.2023.1225957. eCollection 2023.
PubMed 37744351Wu X, Chen J, Sun W, Hart DA, Ackermann PW, Ahmed AS. Network proteomic analysis identifies inter-alpha-trypsin inhibitor heavy chain 4 during early human Achilles tendon healing as a prognostic biomarker of good long-term outcomes. Front Immunol. 2023 Jul 6;14:1191536. doi: 10.3389/fimmu.2023.1191536. eCollection 2023.
PubMed 37483617Aufwerber S, Silbernagel KG, Ackermann PW, Naili JE. Comparable Recovery and Compensatory Strategies in Heel-Rise Performance After a Surgically Repaired Acute Achilles Tendon Rupture: An In Vivo Kinematic Analysis Comparing Early Functional Mobilization and Standard Treatment. Am J Sports Med. 2022 Dec;50(14):3856-3865. doi: 10.1177/03635465221129284. Epub 2022 Nov 2.
PubMed 36322396Chen J, Wang J, Hart DA, Ahmed AS, Ackermann PW. Complement factor D as a predictor of Achilles tendon healing and long-term patient outcomes. FASEB J. 2022 Jun;36(6):e22365. doi: 10.1096/fj.202200200RR.
PubMed 35596679Aufwerber S, Edman G, Gravare Silbernagel K, Ackermann PW. Changes in Tendon Elongation and Muscle Atrophy Over Time After Achilles Tendon Rupture Repair: A Prospective Cohort Study on the Effects of Early Functional Mobilization. Am J Sports Med. 2020 Nov;48(13):3296-3305. doi: 10.1177/0363546520956677. Epub 2020 Sep 28.
PubMed 32986466Aufwerber S, Heijne A, Edman G, Silbernagel KG, Ackermann PW. Does Early Functional Mobilization Affect Long-Term Outcomes After an Achilles Tendon Rupture? A Randomized Clinical Trial. Orthop J Sports Med. 2020 Mar 16;8(3):2325967120906522. doi: 10.1177/2325967120906522. eCollection 2020 Mar.
PubMed 32206673Aufwerber S, Heijne A, Gravare Silbernagel K, Ackermann PW. High Plantar Force Loading After Achilles Tendon Rupture Repair With Early Functional Mobilization. Am J Sports Med. 2019 Mar;47(4):894-900. doi: 10.1177/0363546518824326. Epub 2019 Feb 11.
PubMed 30742483Alim MA, Svedman S, Edman G, Ackermann PW. Procollagen markers in microdialysate can predict patient outcome after Achilles tendon rupture. BMJ Open Sport Exerc Med. 2016 Jun 10;2(1):e000114. doi: 10.1136/bmjsem-2016-000114. eCollection 2016.
PubMed 27900179
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Direct Functional Mobilization After Achilles Tendon Rupture on Healing and Outcome
- ClinicalTrials.gov ID
- NCT02318472
- Acronym / sponsor ID
- EarlyM-Achil / VR2012-2510
- Conditions
- Achilles Tendon Rupture, Deep Venous Thrombosis
- Keywords
- Microdialysis, Patient related outcome, Heel rise test, Immobilization, functional mobilization, Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- OPED GmbH
- Study start
- Nov 2013 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Dec 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.
The purpose of this study is to determine whether early mobilization after Achilles tendon rupture can speed up healing, prevent development of venous thromboembolism and improve patient outcome.
Detailed description
Patients with acute Achilles tendon rupture will be screened for eligibility at the Karolinska University Hospital and Södersjukhuset, Stockholm.
One hundred-fifty patients will be included and enrolled and assigned to the interventions either by a third party nurse or by a research nurse. Randomisation will be performed with use of computer-generated random numbers in permuted blocks of four, through an independent software specialist, and consecutively numbered, sealed, opaque envelopes opened after surgery and prior to treatment.
The patients will be randomized to undergo either treatment as usual using plaster cast treatment alone or direct post-operative functional mobilization with a weight-bearing orthosis with adjustable range of motion of the ankle.
The power calculation was based upon data from a recent study reporting a 50% rate of CDU-verified DVT after ATR surgery (Domeij-Arverud et a. 2015). We estimated early functional mobilization (EFM) to confer a 50% risk reduction. Sixty-three patients in each group were required to detect a difference of 25% in the incidence of DVT (two-sided type-I error rate = 5%; power = 80%). We decided to include 150 patients to counteract drop-outs. On recommendations from the ethical committee, a ratio of 2:1 was chosen, since our hypothesis was that the EFM group would perform better.
The endpoint of the first part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair. The sample size for the outcome in the microdialysis study was calculated on a difference of the glutamate metabolite of 12 µM between the two groups. For this power analysis, we used a glutamate standard difference of 15 µM resulting from a previous study. It was determined that a sample size of 25 patients per group would be necessary to detect the glutamate difference with 80% power when alpha was set equal to 5%. Anticipating that we would lose 10% of participants enrolled, we plan to enroll 27 patients in each group for microdialysis.
The primary aim of the short-term follow up of this randomized, controlled trial was to assess the efficacy of EFM to reduce the DVT incidence after ATR surgery, at two and six weeks post-operatively, compared to treatment-as-usual, i.e. two weeks of plaster cast followed by four weeks' orthosis immobilization. The secondary aim was to evaluate the effect of patient intrinsic factors (age, BMI, calf circumference, ankle range of motion, pain and fear of movement) and patient extrinsic factors (amount of weightbearing, number of daily steps) on the risk of sustaining a DVT.
The primary aim with the long-term follow up is to investigate the effect of early postoperative functional mobilization compared to immobilization on patient-reported function, health, fear of movement, physical activity level, and differences in functional capacity. The second aim is to explore if the occurrence of DVT postoperatively effects functional outcome in the long-term after surgical treatment of ATR.
Additional aims:
The primary aim of the second part of this study was to assess the number of steps and the amount of loading in a weight bearing orthosis during the first six weeks post-surgical ATR repair. A secondary purpose was to investigate if the amount of loading was correlated to fear of movement or/and pain.
The aim with this substudy is to describe differences between the two groups over time regarding tendon elongation, differences in muscle cross-sectional area and differences in tendon cross-sectional area (on the injured side) and to examine if the differences can predict functional outcome in the long-term and if any of the follow-up occasions are most important for long-term functional outcome.
Few studies have evaluated outcome more than one year after injury. The aim of this substudy is to investigate differences in outcome at 3 years after injury between the patients that sustained a DVT and those who did not sustain a DVT. Another aim is to compare the two intervention groups over 3-years time.
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 | Experimental | Device: VACOped orthosisFunctional mobilization initiated directly post-operative with a weight-bearing VACOped orthosis with adjustable range of motion of the ankle |
| Immobilization | Active comparator | Device: Plaster castTreatment as usual using plaster cast immobilization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute unilateral ATR, operated on within 96 hours
- Age between 18 and 75 years
Key exclusion criteria (11 listed)
- Inability to give informed consent
- Current anticoagulation treatment (including high dose acetylsalicylic acid)
- Planned follow-up at other hospital
- Inability to follow instructions
- Known kidney failure
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 |
|---|---|---|
| VACOped orthosisWeight-bearing orthosis with adjustable range of motion of the ankle | Device | Early mobilization |
| Plaster castLower limb plaster cast | Device | Immobilization |
Primary outcome
Deep venous thrombosis (DVT)
Time frame: Six weeks
At 2 and 6 weeks postoperatively the number of participants with DVT will be assessed by compression duplex ultrasound (CDU)
19 secondary outcomes
Functional outcome - muscular endurance tests (heel-rise)
Time frame: Four years
Patient-reported outcome - ATRS
Time frame: Four years
Patient-reported outcome - EQ-5D
Time frame: One year
Physical activity - PAS
Time frame: Four years
Patient-reported outcome - The Foot and Ankle Outcome Score (FAOS)
Time frame: One year
Patient-reported outcome - RAND 36 Health and Quality of Life questionnaire
Time frame: One year
Patient-reported outcome - Tampa Scale of Kinesiophobia, Swedish version, TSK-SV
Time frame: One year
Plantar force loading
Time frame: Six weeks
Patient-reported diary - self-reported loading
Time frame: Two weeks
Patient-reported diary - pain ratings
Time frame: Two weeks
Patient-reported diary - steps/day
Time frame: Two weeks
Calf circumference
Time frame: Four years
Ankle dorsiflexion
Time frame: Six weeks
Tendon length measurement
Time frame: Four years
Tendon thickness measurement
Time frame: One year
Muscle volume of the calf muscles
Time frame: One year
Thickness of the calf muscles
Time frame: One year
Achilles Tendon resting angle (ATRA)
Time frame: Four years
3D gait analysis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 37941888Saarensilta A, Aufwerber S, Gravare Silbernagel K, Ackermann P. Early Tendon Morphology as a Biomarker of Long-term Patient Outcomes After Surgical Repair of Achilles Tendon Rupture: A Prospective Cohort Study. Orthop J Sports Med. 2023 Nov 6;11(11):23259671231205326. doi: 10.1177/23259671231205326. eCollection 2023 Nov.
- Derived from this study: PubMed 37744351Chen J, Wang J, Hart DA, Zhou Z, Ackermann PW, Ahmed AS. Complement factor D regulates collagen type I expression and fibroblast migration to enhance human tendon repair and healing outcomes. Front Immunol. 2023 Sep 6;14:1225957. doi: 10.3389/fimmu.2023.1225957. eCollection 2023.
- Derived from this study: PubMed 37483617Wu X, Chen J, Sun W, Hart DA, Ackermann PW, Ahmed AS. Network proteomic analysis identifies inter-alpha-trypsin inhibitor heavy chain 4 during early human Achilles tendon healing as a prognostic biomarker of good long-term outcomes. Front Immunol. 2023 Jul 6;14:1191536. doi: 10.3389/fimmu.2023.1191536. eCollection 2023.
- Derived from this study: PubMed 36322396Aufwerber S, Silbernagel KG, Ackermann PW, Naili JE. Comparable Recovery and Compensatory Strategies in Heel-Rise Performance After a Surgically Repaired Acute Achilles Tendon Rupture: An In Vivo Kinematic Analysis Comparing Early Functional Mobilization and Standard Treatment. Am J Sports Med. 2022 Dec;50(14):3856-3865. doi: 10.1177/03635465221129284. Epub 2022 Nov 2.
- Derived from this study: PubMed 35596679Chen J, Wang J, Hart DA, Ahmed AS, Ackermann PW. Complement factor D as a predictor of Achilles tendon healing and long-term patient outcomes. FASEB J. 2022 Jun;36(6):e22365. doi: 10.1096/fj.202200200RR.
- Derived from this study: PubMed 32986466Aufwerber S, Edman G, Gravare Silbernagel K, Ackermann PW. Changes in Tendon Elongation and Muscle Atrophy Over Time After Achilles Tendon Rupture Repair: A Prospective Cohort Study on the Effects of Early Functional Mobilization. Am J Sports Med. 2020 Nov;48(13):3296-3305. doi: 10.1177/0363546520956677. Epub 2020 Sep 28.
- Derived from this study: PubMed 32206673Aufwerber S, Heijne A, Edman G, Silbernagel KG, Ackermann PW. Does Early Functional Mobilization Affect Long-Term Outcomes After an Achilles Tendon Rupture? A Randomized Clinical Trial. Orthop J Sports Med. 2020 Mar 16;8(3):2325967120906522. doi: 10.1177/2325967120906522. eCollection 2020 Mar.
- Derived from this study: PubMed 30742483Aufwerber S, Heijne A, Gravare Silbernagel K, Ackermann PW. High Plantar Force Loading After Achilles Tendon Rupture Repair With Early Functional Mobilization. Am J Sports Med. 2019 Mar;47(4):894-900. doi: 10.1177/0363546518824326. Epub 2019 Feb 11.
- Derived from this study: PubMed 27900179Alim MA, Svedman S, Edman G, Ackermann PW. Procollagen markers in microdialysate can predict patient outcome after Achilles tendon rupture. BMJ Open Sport Exerc Med. 2016 Jun 10;2(1):e000114. doi: 10.1136/bmjsem-2016-000114. eCollection 2016.
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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.
Paul W Ackermann, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VACOped orthosis and Plaster cast in people with Achilles Tendon Rupture and Deep Venous Thrombosis, run by Karolinska University Hospital 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Mar 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 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?
Results are not available in the source record.
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?
Deep venous thrombosis (DVT) (time frame: Six 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 NCT02318472, which also lists 9 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 6 Mar 2024.