N/A
N=150
Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture
Rupture · Venous Thromboembolism · Venous Thrombosis · Surgical Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT01317160 ↗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
| Outcome | Result | p-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
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.