NCT01317160

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 15, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

4.4 years

First QC Date

March 16, 2011

Results QC Date

January 18, 2016

Last Update Submit

March 5, 2024

Conditions

RuptureVenous ThromboembolismVenous ThrombosisSurgical Wound Infection

Keywords

Achilles TendonImmobilizationWound HealingIntermittent Pneumatic CompressionUltrasonographyMicrodialysis

Outcome Measures

Primary Outcomes (1)

  • Venous Thromboembolic Events (VTE)

    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.

    2 weeks

Secondary Outcomes (5)

  • Functional Outcome - Muscular Endurance Tests (Heel-rise)

    one year

  • Venous Thromboembolic Events (VTE)

    6 weeks

  • Patient-reported Outcome

    One year

  • Microdialysis

    2 weeks

  • Time From Injury to Surgery

    1 year

Other Outcomes (2)

  • Surgeon Sex

    Surgery will be performed within 10 days of injury

  • Surgeon Experience

    Surgery will be performed within 10 days of injury

Study Arms (2)

Routine care: Plaster Cast Treatment

NO INTERVENTION

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

Intermittent pneumatic compression (IPC)

EXPERIMENTAL

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

Device: Intermittent pneumatic compression (IPC)

Interventions

Intermittent pneumatic compression (IPC)DEVICE

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.

Also known as: VenaFlow Elite system, VenaFlow® System
Intermittent pneumatic compression (IPC)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Achilles tendon rupture operated on within 96 hours of diagnose.

You may not qualify if:

  • Inability or refusal to give informed consent for participation in the study
  • Ongoing treatment with anticoagulant therapy
  • Inability to comply with the study instructions
  • Known kidney disorder
  • Heart failure with pitting oedema
  • Thrombophlebitis
  • Recent thromboembolic event (during the preceding 3 months)
  • Recent surgery (during the preceding month)
  • Presence of known malignancy
  • Current bleeding disorder
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (8)

  • Domeij-Arverud E, Labruto F, Latifi A, Nilsson G, Edman G, Ackermann PW. Intermittent pneumatic compression reduces the risk of deep vein thrombosis during post-operative lower limb immobilisation: a prospective randomised trial of acute ruptures of the Achilles tendon. Bone Joint J. 2015 May;97-B(5):675-80. doi: 10.1302/0301-620X.97B5.34581.

    PMID: 25922463RESULT

  • Abdul Alim M, Domeij-Arverud E, Nilsson G, Edman G, Ackermann PW. Achilles tendon rupture healing is enhanced by intermittent pneumatic compression upregulating collagen type I synthesis. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):2021-2029. doi: 10.1007/s00167-017-4621-8. Epub 2017 Jul 1.

    PMID: 28668970RESULT

  • Chen J, Wang J, Hart DA, Zhou Z, Ackermann PW, Ahmed AS. Complement factor D regulates collagen type I expression and fibroblast migration to enhance human tendon repair and healing outcomes. Front Immunol. 2023 Sep 6;14:1225957. doi: 10.3389/fimmu.2023.1225957. eCollection 2023.

    PMID: 37744351DERIVED

  • Wu X, Chen J, Sun W, Hart DA, Ackermann PW, Ahmed AS. Network proteomic analysis identifies inter-alpha-trypsin inhibitor heavy chain 4 during early human Achilles tendon healing as a prognostic biomarker of good long-term outcomes. Front Immunol. 2023 Jul 6;14:1191536. doi: 10.3389/fimmu.2023.1191536. eCollection 2023.

    PMID: 37483617DERIVED

  • Chen J, Wang J, Wu X, Simon N, Svensson CI, Yuan J, Hart DA, Ahmed AS, Ackermann PW. eEF2 improves dense connective tissue repair and healing outcome by regulating cellular death, autophagy, apoptosis, proliferation and migration. Cell Mol Life Sci. 2023 Apr 21;80(5):128. doi: 10.1007/s00018-023-04776-x.

    PMID: 37084140DERIVED

  • Chen J, Wang J, Hart DA, Ahmed AS, Ackermann PW. Complement factor D as a predictor of Achilles tendon healing and long-term patient outcomes. FASEB J. 2022 Jun;36(6):e22365. doi: 10.1096/fj.202200200RR.

    PMID: 35596679DERIVED

  • Svedman S, Juthberg R, Edman G, Ackermann PW. Reduced Time to Surgery Improves Patient-Reported Outcome After Achilles Tendon Rupture. Am J Sports Med. 2018 Oct;46(12):2929-2934. doi: 10.1177/0363546518793655. Epub 2018 Aug 31.

    PMID: 30169112DERIVED

  • Alim MA, Svedman S, Edman G, Ackermann PW. Procollagen markers in microdialysate can predict patient outcome after Achilles tendon rupture. BMJ Open Sport Exerc Med. 2016 Jun 10;2(1):e000114. doi: 10.1136/bmjsem-2016-000114. eCollection 2016.

    PMID: 27900179DERIVED

MeSH Terms

Conditions

RuptureVenous ThromboembolismVenous ThrombosisSurgical Wound Infection

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Wounds and InjuriesThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

Title
Dr. Paul W. Ackermann
Organization
Karolinska university Hospital
paul.ackermann@karolinska.se
+46851770000

Study Officials

  • Paul W Ackermann, MD, PhD

    Karolinska University Hospital, 171 76 Stockholm, SWEDEN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2015

Study Completion

September 1, 2018

Last Updated

March 7, 2024

Results First Posted

March 15, 2016

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Plan to share data on primary outcome (DVT)

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Starting 12 months after publication the data will be available for 10 years after the study is published.
Access Criteria
Contact PI.

Locations

SE(1)