Achilles Tendon Ruptures, Immobilization, Muscle Atrophy, Venous Thromboembolism (VTE)
Conditions
Keywords
neuromuscular electrical stimulation, duplex ultrasound
Brief summary
Acute Achilles tendon rupture (ATR) is an injury that is commonly associated with complications, such as blood clotting, muscle loss and tendon lengthening, all of which affect the long-term outcome and return to sports. These complication are related to the treatment of ATR with lower leg immobilization in a boot. The investigators aim to demonstrate that an intervention with calf neuromuscular electrical stimulation (C-NMES) during leg immobilization after ATR can 1) reduce blood clots, 2) lower the degree of muscle loss, 3) decrease tendon lengthening and 4) improve long-term outcome.
Detailed description
The participants will be divided by chance into two separate groups that compare standard treatment (control group) with C-NMES in addition to standard treatment (intervention group). A total of 220 patients with diagnosed ATR will be included. The control group will be treated according to the standard regimen with a lower leg immobilization in a stable orthosis during eight weeks. The intervention group will during the eight weeks lower limb immobilization receive an additional intervention with C-NMES underneath the orthosis. The total number of blood clots, venous thromboembolism incidence, up to mobilization, is defined as deep venous thrombosis (leg blood clots) assessed by screening duplex ultrasound, or pulmonary embolism (lung blood clots). Calf muscle loss, tendon length, and weight-bearing, will be studied at two and eight weeks. At six weeks and 12 months, validated self-reported function (ATRS) and self-reported health, return to sports, calf muscle function, and tendon length will be recorded for comparison between the two treatment groups. Secondary outcomes are coagulation factors, healing biomarkers and cardiovascular biomarkers. The results of this study should contribute to an improved treatment regimen after ATR that allows for a safer and quicker return to activity and sports. Adjuvant NMES can readily be implemented in daily healthcare to lower complication risks, improve healing, reduce healthcare costs and improve return to sports.
Interventions
DEVICENeuromuscular Electrical Stimulation
Patients will be instructed to apply the wearable NMES-therapy continuously, both day and night at least 10h/daily.
Sponsors
Danderyd Hospital
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with acute unilateral Achilles tendon rupture * Included within 10 days after injury.
Exclusion criteria
* Inability to give consent to participate, * ongoing treatment with anticoagulants, * known allergy to contrast agents, * planned follow-up at another hospital, * inability to follow instructions, * known renal failure, * heart failure with pitting edema, * thrombophlebitis, * thromboembolic disease within the last 3 months, * previous surgery of the tendon, * known malignancy, * hemophilia, * pregnancy, * treatment with high doses of acetylsalicylic acid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Venous thromboembolic events (VTE) | 8 weeks | VTE, is defined as symptomatic/ asymptomatic DVT assessed at the end of immobilization, i.e. 8 weeks, by compression duplex ultrasound (CDU) screening, or symptomatic pulmonary embolism detected by computer tomography. Assessors of CDU will be skilled ultrasonographists, masked to the treatment allocation. The CDU-examination will document absence/presence of thrombus in the calf, popliteal and femoral veins separately |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Callus production | 8 weeks | Callus production will be assessed at eight weeks using microdialysis followed by quantification of procollagens for tendon healing. |
| Treatment adherence | 8 weeks | Treatment adherence to allocated treatment, NMES, will be registered by the patient and by the device. |
| Adverse events | 8 weeks | Adverse events that will be registered are 1) Any damage to the skin of the legs including infection. 2) Any reasons for prematurely stopping the NMES. 3) Any fall associated with significant injury occurring within 6 weeks of enrollment. The frequency of the adverse events of each group will be presented. |
| Fasting blood glucose | 8 weeks | Fasting blood glucose will be assessed at inclusion and at eight weeks. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) will be considered normal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) will be considered considered prediabetes. If it is 126 mg/dL (7 mmol/L) or higher it will be considered diabetic. |
| Cholesterol levels | 8 weeks | Will be assessed at inclusion and at eight weeks. Total cholesterol less than 200 Mmol/l will be considered good. Total cholesterol 200-239 Mmol/l will be considered moderately elevated. Total cholesterol 240 Mmol/l or higher will be considered high. |
| Blood pressure | 8 weeks | Systolic blood pressure less than 120 mmHg and diastolic blood pressure less than 80 mmHg will be considered optimal. Systolic blood pressure between 120-129 mmHg and diastolic blood pressure between 80-84 mmHg will be considered normal. Systolic blood pressure between 130-139 mmHg and diastolic blood pressure between 85-89 mmHg will be considered slightly high. Systolic blood pressure greater or equal to 140 mmHg and diastolic blood pressure greater or equal to 90 mmHg will be considered high. |
| Patient function | 12 months | Functional evaluation of healing will be performed by the validated heel-rise test at one-year post-injury. |
| Tendon lengthening | 12 months | At 2 and 6 weeks and 6 and 12 months postoperatively, B-mode ultrasound imaging will be performed to assess the length of the Achilles tendon. The injured and healthy sides will be compared. A larger difference between the sides will be considered a worse outcome. |
| Patient-reported outcome - ATRS | 12 months | The validated Achilles Tendon total Rupture Score (ATRS) will be assessed at 6 and 12 months. \[0-100, a higher score mean a better outcome\]. |
| Patient-reported outcome - EuroQol (EQ-5D-5L) | 12 months | The validated EuroQol (EQ-5D-5L), will be assessed at 6 and 12 months. \[A five-digit code will be generated, where each digit will be between 1-5, a lower digit in each position mean a better outcome in that dimension\]. The five-digit code will generate an index between 0-1, where a lower value is worse outcome. The index will be compared with a country specific index. |
| Blood-flow quantification | 8 weeks | VTE-preventive mechanisms will be analyzed at the eight week visit by assessments by blood-flow quantification using ultrasound. Peak popliteal/femoral blood velocity (cm/second) will be calculated using custom ultrasound software. |
| Coagulation factors | 8 weeks | VTE-preventive mechanisms will be analyzed at the baseline and eight week visit by assessments of coagulation factors. Overall hemostatic potential (OHP), D-dimer, endogen trombin potential, fibrinogen, trombin antitrombin complex, plasmin antiplasmin complex, will be assessed in blood samples. The percentage increase/decrease between baseline and eight weeks assessment will be compared between groups. |
| Muscle atrophy | 12 months | At 2 and 6 weeks and 6 and 12 months postoperatively, B-mode ultrasound imaging will be performed to assess the cross-sectional area (CSA) of the Achilles tendon, the gastrocnemius CSA, as well as the thickness of soleus. The injured and healthy sides will be compared. |
Contacts
Primary ContactLuigi Belcatro, Res.Nurse
Outcome results
None listed