Clinical trial NCT01984190: Multicenter Registry for Effectiveness Analysis of ActiveCare+S.F.T® Mobile Compression Device for Thrombosis Prevention in Hip and Knee Arthroplasty
Official title: ActiveCare+S.F.T® Outcomes Registry (ACOR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: venous thromboembolism
deep vein thrombosis
pulmonary emboli
hip arthroplasty
knee arthroplasty
efficacy
mobile compression device
mechanical device
prophylaxis.
Lead sponsor: Medical Compression Systems
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The registry will include all Adult patients scheduled for elective unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA), or unicondylar knee arthroplasty (UKA), where the orthopaedic surgeon is using the ActiveCare+S.F.T® mobile compression device as a monotherapy for venous thromboembolism prevention.

Brief summary: Venous thromboembolic events (VTE), either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. This multicenter Clinical Registry is aimed at collecting large volume clinical effectiveness data of ActiveCare+S.F.T® mobile compression device +/- aspirin in lowering the potential risk of venous thromboembolism (VTE) prophylaxis in patients undergoing primary lower extremity total joint arthroplasty. The results can then be compared to pharmacology protocols.

Detailed description: Orthopaedic surgeons at ten sites in the United States will participate in a registry to collect postoperative venous thromboembolism incidence in lower extremity joint arthroplasty patients using the mobile compression device. Patients will be included in the registry if they are eighteen years of age or older and undergoing primary unilateral hip arthroplasty (including hip resurfacing) or primary unilateral knee arthroplasty (including unicondylar knee arthroplasty) using only the mobile compression device with or without aspirin for venous thromboembolism prevention. Patients will be excluded if they are scheduled for a revision surgery, have a history of venous thromboembolism, a coagulation disorder, a solid tumor malignancy within the last five years, or had a major surgery in the three months prior to the joint surgery. An attempt to enroll every patient consecutively will be made at each institution and only those patients who did not meet the inclusion criteria or declined participation will not be included. Use of the ActiveCare+S.F.T® mobile compression device will begin intra-operatively and continue for a minimum of 10 days. The decision to use aspirin is at the discretion of each surgeon. All patients will be evaluated within three months postoperatively, documenting evidence of deep venous thrombosis or pulmonary emboli.

1. Registry Procedures

   * Patients will complete a 1 page questionnaire regarding their usage of the mechanical compression device. The de-identified information from the questionnaire will be entered into a web based computer database by a research coordinator at each of the ten sites. The web based registry was created by a third party (Global Visions Technology, Inc.).
   * Once the study is closed to enrollment and data entry is complete, the database manager will pull all the data from the web based registry and import into a statistical software program for analysis.
   * A power analysis found that sample sizes of 1500 in the device group and any drug group would be sufficient to achieve power in excess of 90% to detect a non-inferiority margin difference between the venous thromboembolism proportions in the two groups of 1.0%. In these calculations, we considered drug group venous thromboembolism rates between 0.5% and 1.0% and the device group venous thromboembolism rate was taken to be the drug group rate +1.0% under the null hypothesis of inferiority. Power was computed for the case when the actual device venous thromboembolism rate was identical to the drug comparator rate. The test statistic used was the one-sided score test, with the significance level set at 0.025.
   * SPSS version 13.0 (SPSS, Chicago, Illinois) and NCSS Version 7.1.21 (NCSS LLC, Kaysville, Utah) will be used for analysis of the registry data. Means will be calculated to describe continuous variables (age, height, weight) and frequencies will be calculated to describe categorical variables (surgery type, aspirin use, incidence of symptomatic venous thromboembolism). Upper bound 97.5% CIs will be calculated around the observed venous thromboembolism rate difference between the mobile compression device and each drug comparator.
2. Quality Factors

   * Institutional Review Board (IRB)approval will be obtained at each site.
   * Patient privacy will be protected per the Health Insurance Portability and Accountability Act (HIPAA). Patients will remain anonymous; all patient identifiers will be purged from the data at the originating center. Patient care will NOT be affected in any way by participation in the study.
   * Accounts were set up for each coordinator with respective passwords for security. A data entry guide will be distributed to each coordinator, which will give instructions for entering each variable. Additionally, each coordinator will be required to view an instructional video online before they will be permitted to begin data entry into the registry.
   * Validation criteria will be set up for each field so that data are entered in the correct format (eg, must enter four digits for the year, sex must be entered as "M" or "F", etc). Ranges will be constructed to minimize data entry errors (eg, "number of days the device was worn" will be restricted to a number between 0 and 15 only). If any required fields are left blank, a prompt will come up to ask the coordinator to fill in the missing data. The record will be marked as incomplete until all required fields are completed. Each of the 10 sites will only have access to view their own data.
   * Periodic data checks will be performed by the database manager, who will query all fields and to keep track of how enrollment is going at each site. When the study is closed, the database will be locked by the database manager.

Eligibility criteria: Inclusion Criteria:

* Adult patients (Age \>18 yrs).
* Patient intended to undergo elective primary unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA), or unicondylar knee arthroplasty (UKA).
* Patient is using only ActiveCare+S.F.T® +/- aspirin for venous thromboembolism (VTE) prevention(Aspirin (ASA) can be prescribed at the discretion of the surgeon).

Exclusion Criteria:

* Patient with known coagulation disorder
* Patient currently treated with anticoagulant medications.
* Patients with current signs and symptoms of or history of deep vein thrombosis(DVT) or pulmonary embolism (PE).
* Patients currently suffering from a solid tumor malignancy.
* Patients who underwent major surgery procedure within 3 months prior to participation in the registry

Primary outcomes:
measure: Incidence of deep venous thrombosis or pulmonary emboli
timeFrame: Within 3 months post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Specialty Orthopaedics
state: Alaska
city: La Jolla
country: United States
facility: Shiley Center for Orthopaedic Research and Education at Scripps Clinic
state: California
city: Menlo Park
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Baltimore
country: United States
facility: Rubin Institute for Advanced Orthopedics,
state: Maryland
city: Edina
country: United States
facility: Twin Cities Orthopaedics
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine, Department of Orthopaedic Surgery
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bend
country: United States
facility: The Center Orthopedic & Neurosurgical Care &Research
state: Oregon
city: Alexandria
country: United States
facility: Anderson Orthopaedic Clinic
state: Virginia
Study officials:
affiliation: Shiley Center for Orthopaedic Research and Education at Scripps Clinic
name: Clifford W Colwell, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colwell CW Jr, Froimson MI, Mont MA, Ritter MA, Trousdale RT, Buehler KC, Spitzer A, Donaldson TK, Padgett DE. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. J Bone Joint Surg Am. 2010 Mar;92(3):527-35. doi: 10.2106/JBJS.I.00047.
citation: Colwell CW Jr, Froimson MI, Anseth SD, Giori NJ, Hamilton WG, Barrack RL, Buehler KC, Mont MA, Padgett DE, Pulido PA, Barnes CL. A mobile compression device for thrombosis prevention in hip and knee arthroplasty. J Bone Joint Surg Am. 2014 Feb 5;96(3):177-83. doi: 10.2106/JBJS.L.01031.