Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture
Condition: Rupture; Venous Thromboembolism; Venous Thrombosis; Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Rupture; Surgical Wound
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Intermittent pneumatic compression (IPC)
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): VenaFlow Elite system; VenaFlow® System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Achilles Tendon; Immobilization; Wound Healing; Intermittent Pneumatic Compression; Ultrasonography; Microdialysis