Achilles Tendon Rupture - Intervention With Electrical Stimulation

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

Functional evaluation of healing will be performed by the validated heel-rise test at one-year post-injury.

Callus production will be assessed at eight weeks using microdialysis followed by quantification of procollagens for tendon healing.

Treatment adherence to allocated treatment, NMES, will be registered by the patient and by the device.

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 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.

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.

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.

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.

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.

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].

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.

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.

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.