Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
DJO Incorporated
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01317160
First received: March 16, 2011
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Rupture
Venous Thromboembolism
Venous Thrombosis
Surgical Wound Infection
Device: Intermittent pneumatic compression (VenaFlow Elite system)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intermittent Pneumatic Compression Effects on Venous Thromboembolism Incidence and Healing of Achilles Tendon Rupture

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Venous thromboembolic events (VTE) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    At 2 weeks postoperatively the number of participants with VTE events will be assessed by:

    1) DVT detected by compression duplex ultrasound (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.


  • Functional outcome - muscular endurance tests (heel-rise) [ Time Frame: one year ] [ Designated as safety issue: No ]
    The functional outcome will be assessed at 52 weeks post-operatively by validated muscular endurance test, i.e. heel rise test.


Secondary Outcome Measures:
  • Tendon healing using microdialysis and speckle-tracking [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Tendon healing quantified at 2 and 6 weeks by ultrasound using speckle tracking and by microdialysis followed by quantification of markers for tendon repair.

  • venous thromboembolic events (VTE) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    At 6 weeks postoperatively the number of participants with VTE events will be assessed by:

    1) DVT detected by compression duplex ultrasound (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.


  • Patient-reported outcome and physical activity [ Time Frame: One year ] [ Designated as safety issue: No ]
    The patients' symptoms and physical activity levels were assessed using four reliable and valid scores; the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D).


Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional Plaster Cast Treatment
Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
Experimental: Intermittent pneumatic compression
Two weeks of intermittent pneumatic calf compression applied by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.
Device: Intermittent pneumatic compression (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.
Other Names:
  • VenaFlow Elite system
  • VenaFlow® System

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317160

Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Stockholm County Council, Sweden
DJO Incorporated
Investigators
Principal Investigator: Paul W Ackermann, MD, PhD Karolinska University Hospital, 171 76 Stockholm, SWEDEN
  More Information

No publications provided

Responsible Party: Paul Ackermann, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01317160     History of Changes
Other Study ID Numbers: IPC-Achilles, SLL20100168
Study First Received: March 16, 2011
Last Updated: February 7, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Achilles Tendon
Immobilization
Wound Healing
Intermittent Pneumatic Compression
Ultrasonography
Microdialysis

Additional relevant MeSH terms:
Surgical Wound Infection
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Wound Infection
Rupture
Infection
Postoperative Complications
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on April 15, 2014