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N/A N=150 Randomized Double-blind Prevention

Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

Rupture · Venous Thromboembolism · Venous Thrombosis · Surgical Wound Infection

Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Venous Thromboembolic Events (VTE) — 26; 14 participants — p=0.042

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Intermittent pneumatic compression (IPC) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Karolinska University Hospital
Primary completion
Aug 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Venous Thromboembolic Events (VTE)
34; 36 0.737
SECONDARY
Functional Outcome - Muscular Endurance Tests (Heel-rise)
78.5; 82.5; 78.2; 82.6; 83.0; 84.1
SECONDARY
Venous Thromboembolic Events (VTE)
34; 36 0.737
SECONDARY
Patient-reported Outcome
78; 77.8
SECONDARY
Microdialysis
2.05; 3.47
SECONDARY
Time From Injury to Surgery
62.33; 62.18

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01317160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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