Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

Karolinska University Hospital

Status: Completed

Conditions: Venous Thromboembolism; Rupture; Surgical Wound Infection; Venous Thrombosis

Treatments: Device: Intermittent pneumatic compression (IPC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01317160

IPC-Achilles

SLL20100168 (Other Grant/Funding Number)

Details and patient eligibility

About

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 weeks 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.

Full description

The incidence of DVT after Achilles tendon rupture is as high as 30-40% and patients exhibit a prolonged healing process with variable outcome. Moreover, it has been 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Routine care: Plaster Cast Treatment

No Intervention group

Description:

Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion

Intermittent pneumatic compression (IPC)

Experimental group

Description:

Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.

Treatment:

Device: Intermittent pneumatic compression (IPC)