Achilles Tendon Rupture, Ankle Fractures, Venous Thromboembolism
Conditions
Keywords
Achilles tendon, Microdialysis, Immobilization, Wound healing, Intermittent Pneumatic Compression, Ultrasonography
Brief summary
Lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. Thus, there is a need for novel treatments. This study aims to demonstrate in leg immobilized patients who have suffered an ankle fracture (1000 patients) or an Achilles tendon rupture (400 patients) that adjuvant intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow, compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.
Detailed description
The proposed intervention, intermittent pneumatic compression (IPC) is an evidence-based prevention for VTE in hospitalized patients and used in daily practice. IPC is, however, not currently used on outpatients and it is currently unknown if it reduces the risk of VTE during long term leg-immobilization. Plaster cast and orthosis treatments are currently used in daily practice on Achilles tendon ruptures and ankle fractures. At present there is no consensus about using VTE prophylaxis in leg-immobilized patients. Since pharmacoprophylaxis has shown low- or no VTE preventive effects in leg-immobilization, is not recommended by some guidelines. Furthermore, since all patients will undergo clinical examinations and have DVT-screening performed with compression Doppler ultrasound (CDU) removal of leg immobilization this will comprise an extra security for the included patients to detect a VTE. If a VTE is detected clinical guidelines will be followed by initiating chemical VTE-treatment.
Interventions
DEVICEAdjuvant IPC
This IPC-system delivers sequential circumferential compression. The IPC device is mobile and should therefore not restrict patient mobilization, but can be taken off if the patient wants to mobilize independently.
Sponsors
Sahlgrenska University Hospital
Danderyd Hospital
Stockholm South General Hospital
Uppsala University Hospital
Gävle Hospital
Höglandssjukhuset Eksjö
Norrtälje Hospital
Östersund Hospital
Helsingborgs Hospital
Uddevalla Hospital
Norra Älvsborgs Länssjukhus
Istituto Ortopedico Rizzoli
Lugano Regional Hospital
Alingsås Lasarett
University Hospital, Akershus
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Acute unilateral Achilles tendon rupture or isolated Ankle Fracture * Treatment starts within 10 days in a hospital setting
Exclusion criteria
* Inability or refusal to give informed consent for participation in the study * Inability to comply with the study instructions * Known kidney disorder * Heart failure with pitting oedema * Presence of known malignancy * Current bleeding disorder * Pregnancy * Planned follow-up at another hospital * Pilon fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous Thromboembolic Events (VTE) | Up til the time of removal of leg immobilization, approx. 6-8 weeks | The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported Outcome - FAOS | 6 months and 1 year | symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS) |
| Patient reported Outcome - OMAS | 6 months and 1 year | symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS) |
| Patient reported Outcome - EQ-5D-5L | 6 months and 1 year | symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L). |
| Functional outcome - muscular endurance tests (heel-rise) | 1 year | Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury. |
| Patient reported Outcome - ATRS | 6 months and 1 year | symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS) |
| VTE-preventive mechanisms | 6 weeks | VTE-preventive mechanisms will be analyzed at the 6 week visit by assessments of profibrinolysis and coagulation factors as well as by blood-flow quantification . |
| Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC | 6-8 weeks | Efficacy of LMWH with and without the use of IPC as to prevent VTE will be studied in order to confirm the efficency of a commonly used drug for VTE prophylaxis. |
| Patient mortality | 1year and 2 years | Mortality of patients included will be recorded and investigated for cause of death. If the cause of death is VTE, this will be reported. The overall mortality rate in this study is expected to be low. Mortality will be investigated via patient journals at one year after study inclusion, and at 2 years via national mortality register. |
| Health economic analyses | 2 years | Together with Karolinska Institutet, LIME, the trial treatment effects will involve a within-trial evaluation of cost effectiveness integrated into a decision-analytic model of longer run costs and health effects |
| Callus production | 6 weeks | Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing. |
Countries
Sweden
Contacts
Primary ContactLuigi Belcastro, RN
Backup ContactSimon Svedman, MD
Outcome results
None listed