This trial is active, not recruiting.

Conditions rupture, venous thromboembolism, venous thrombosis, surgical wound infection
Treatment intermittent pneumatic compression (ipc)
Sponsor Karolinska University Hospital
Collaborator Stockholm County Council, Sweden
Start date March 2011
End date August 2013
Trial size 150 participants
Trial identifier NCT01317160, IPC-Achilles, SLL20100168


This prospective randomized study aims to determine whether intermittent pneumatic compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures.

At two weeks post surgery, the IPC intervention will be ended and both patient groups will be immobilized in an orthosis until follow-up at six weeks.

The endpoint of the first part of the study is VTE events. The primary outcome will be the DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by two ultrasonographers masked to the treatment allocation. Secondary outcome will be the DVT-incidence at 6 weeks.

1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography.

The endpoint of the second part of the study is tendon healing quantified at 2, 4 and 6 weeks by ultrasound using speckle tracking and by microdialysis followed by quantification of markers for tendon repair.

The endpoint of the third part of the study is the functional outcome of the patients at one year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, outcomes assessor)
Primary purpose prevention
(No Intervention)
Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.
intermittent pneumatic compression (ipc) VenaFlow Elite system
6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute.

Primary Outcomes

Venous thromboembolic events (VTE)
time frame: 2 weeks

Secondary Outcomes

Functional outcome - muscular endurance tests (heel-rise)
time frame: one year
venous thromboembolic events (VTE)
time frame: 6 weeks
Patient-reported outcome and physical activity
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Achilles tendon rupture operated on within 96 hours of diagnose. Exclusion Criteria: 1. Inability or refusal to give informed consent for participation in the study 2. Ongoing treatment with anticoagulant therapy 3. Inability to comply with the study instructions 4. Known kidney disorder 5. Heart failure with pitting oedema 6. Thrombophlebitis 7. Recent thromboembolic event (during the preceding 3 months) 8. Recent surgery (during the preceding month) 9. Presence of known malignancy 10. Current bleeding disorder 11. Pregnancy

Additional Information

Official title Intermittent Pneumatic Compression Effects on Venous Thromboembolism Incidence and Healing of Achilles Tendon Rupture
Principal investigator Paul W Ackermann, MD, PhD
Description Recently, the incidence of DVT after Achilles tendon rupture was demonstrated as high as 30-40%. Moreover it was demonstrated that low molecular weight heparin had no effect on preventing DVT after Achilles tendon surgery. Whether intermittent pneumatic compression (IPC) can prevent DVTs and improve healing after Achilles tendon rupture has to our knowledge not been tested before.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.