An interventional study of Adjuvant IPC in Achilles Tendon Rupture, Ankle Fractures and Venous Thromboembolism, sponsored by Karolinska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Prevention
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.
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.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.
Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
Device: Adjuvant 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.
Venous Thromboembolic Events (VTE)
The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism
Time frame: Up til the time of removal of leg immobilization, approx. 6-8 weeks
Patient reported Outcome - ATRS
symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)
Time frame: 6 months and 1 year
Patient reported Outcome - FAOS
symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)
Time frame: 6 months and 1 year
Patient reported Outcome - OMAS
symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)
Time frame: 6 months and 1 year
Patient reported Outcome - EQ-5D-5L
symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).
Time frame: 6 months and 1 year
Functional outcome - muscular endurance tests (heel-rise)
Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury.
Time frame: 1 year
Callus production
Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.
Time frame: 6 weeks
VTE-preventive mechanisms
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 .
Time frame: 6 weeks
Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC
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.
Time frame: 6-8 weeks
Patient mortality
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.
Time frame: 1year and 2 years
Health economic analyses
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
Time frame: 2 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be shared on reasonable requests.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: After completion of the study.
Access criteria: Data will be shared on reasonable requests to the steering committee.
Started Sep 2018 (actual). Primary completion is estimated for Dec 2024, 75 months after the start.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 75 months is above that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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