- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04979026
Clinical Investigation of a Novel Approach for the Prevention of Deep Venous Thrombosis After Total Knee Replacement
Venous thromboembolism, including deep vein thrombosis (DVT), has long been recognized as the most frequent complication within 7 to 14 days after orthopedic surgery, especially total joint arthroplasty. Without prophylactic therapy, the incidence of DVT and pulmonary embolism reaches up to 60% following orthopedic surgery. The possible damage to the vessel wall during the operation, the venous stasis caused by long-term bed rest, and the hypercoagulability of the blood after the surgery are the 3 main reasons for the formation of DVT. In most cases, the thrombi resolve spontaneously; however, some of them (about 1~4%) may develop into symptomatic and even fatal DVT.
Ankle pumping exercise is currently suggested for the patients with joint placement surgery to prevent the formation of lower-extremity DVT after orthopedic surgery. However, the compliance of the exercise at home is unclear. In order to remind the patients to the active ankle exercise and record the executive rate, a device was developed to help the patient to exercise in the hospital and at home. The device will remind the patient to exercise at specific time point by verbal and vibrations, and detect the range of motion during the exercise for further analysis. The aim of this study is to access the effect of a non-invasive novel device in preventing the formation of lower limb DVT. Maximum venous outflow, maximum venous capacity, and blood rheology were measured and the incidence of DVT was recorded for the data analysis.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Background. Deep vein thrombosis (DVT) has long been recognized as the most frequent complication that occurs 7-14 days after total knee replacement (TKR). Physical therapy, including active ankle pumping exercises and intermittent pneumatic compression, is suggested for the prevention of DVT. However, the exercise implementation rate is not clear, particularly at home. In order to remind the patients to exercise after TKR, a watch with voice and vibration alarms at the set time was used.
Objective The first aim of this study was to compare the effect of active ankle movement with and without reminders on the prevention of DVT. The second aim was to compare the difference in the effect of intermittent pneumatic compression and active ankle movement on the prevention of DVT.
Design. A Pilot Randomized Controlled Trial Methods. The patients were divided into three groups according to the therapeutic protocols. The patients in group 1 conducted active ankle pumping without any reminders, those in group 2 underwent intermittent pneumatic compression, and those in group 3 conducted active ankle pumping with a regular watch alarm. The parameters of blood flow, namely peak flow velocity and flow volume, in the bilateral common femoral vein and popliteal vein on the 1st, 3rd, and 14th days after surgery were measured using the echo technique, as an index to evaluate the effect of DVT prevention among the three groups.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Changhua, Taiwan, 500
- Show Chwan Memorial Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- patients who underwent total knee replacement surgery
Exclusion Criteria:
- Patients with a history of cardiovascular disease, such as DVT, dyslipidemia, hypertension, myocardial infarction, and hemorrhagic disease were excluded from this study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: active ankle pumping without any reminders
In group 1, active ankle pumping exercise for the operative limb was performed without any reminder during hospitalization and at home after being discharged.
|
|
|
Comparatore attivo: intermittent pneumatic compression
In group 2, intermittent pneumatic compression was applied to the operative low limb during hospitalization, while active ankle pumping exercise was adopted without any reminder after discharge.
|
In this group, intermittent pneumatic compression was applied to the operative low limb during hospitalization, while active ankle pumping exercise was adopted without any reminder after discharge.
|
|
Sperimentale: active ankle pumping with a regular watch alarm
In group 3, in addition to the active ankle pumping exercise for the operative limb, the patients were reminded to exercise at specific time points with a vocal alarm and vibration through a wrist watch during the hospitalization period and at home after discharge.
The watch was continuously used until the 14th day when the patients returned to the hospital for examination.
|
In addition to the active ankle pumping exercise for the operative limb, the patients were reminded to exercise at specific time points with a vocal alarm and vibration through a wrist watch during the hospitalization period and at home after discharge.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
change of peak flow velocity
Lasso di tempo: The peak flow velocity was determined on the 1st, 3rd, and 14th days after surgery.
|
The peak flow velocity was directly detected using the Doppler images.
The examination was conducted by an experienced technician.
|
The peak flow velocity was determined on the 1st, 3rd, and 14th days after surgery.
|
|
change of flow volume
Lasso di tempo: The flow volume was determined on the 1st, 3rd, and 14th days after surgery.
|
The flow volume was directly detected using the Doppler images.
The examination was conducted by an experienced technician.
|
The flow volume was determined on the 1st, 3rd, and 14th days after surgery.
|
|
Number of Participants with stasis
Lasso di tempo: Stasis was determined on the 1st, 3rd, and 14th days after surgery.
|
Venous stasis was determined by a peak flow velocity lower than 10 cm/s, and the color of the blood inside the vein represented in the echo image was gray.
In addition, the contour of the vein was compressible under a slight compression force with an echo transducer.
|
Stasis was determined on the 1st, 3rd, and 14th days after surgery.
|
|
Number of Participants with deep venous thrombosis
Lasso di tempo: Deep venous thrombosis was determined on the 1st, 3rd, and 14th days after surgery.
|
If the peak blood flow, flow volume, and blood echo image were the same as that of stasis, but the contour of the vein was incompressible under a slight compression, the cases were recorded as deep venous thrombosis.
|
Deep venous thrombosis was determined on the 1st, 3rd, and 14th days after surgery.
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Anderson DR, Dunbar M, Murnaghan J, Kahn SR, Gross P, Forsythe M, Pelet S, Fisher W, Belzile E, Dolan S, Crowther M, Bohm E, MacDonald SJ, Gofton W, Kim P, Zukor D, Pleasance S, Andreou P, Doucette S, Theriault C, Abianui A, Carrier M, Kovacs MJ, Rodger MA, Coyle D, Wells PS, Vendittoli PA. Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty. N Engl J Med. 2018 Feb 22;378(8):699-707. doi: 10.1056/NEJMoa1712746.
- Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.
- Boylan MR, Perfetti DC, Kapadia BH, Delanois RE, Paulino CB, Mont MA. Venous Thromboembolic Disease in Revision vs Primary Total Knee Arthroplasty. J Arthroplasty. 2017 Jun;32(6):1996-1999. doi: 10.1016/j.arth.2016.12.051. Epub 2017 Jan 11.
- Changulani M, Kalairajah Y, Peel T, Field RE. The relationship between obesity and the age at which hip and knee replacement is undertaken. J Bone Joint Surg Br. 2008 Mar;90(3):360-3. doi: 10.1302/0301-620X.90B3.19782.
- Chen Q, Huang S, Chen X, Feng L, Zhu X. [Clinical efficacy of multi-pattern detumescence after total knee arthroplasty treated with acupoint massage and mild moxibustion]. Zhongguo Zhen Jiu. 2016 May;36(5):471-5. Chinese.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RB19013
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .