Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02993848 |
| Other study ID # |
CON48716 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
December 5, 2016 |
| Last updated |
December 15, 2016 |
| Start date |
December 2016 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
December 2016 |
| Source |
North American Scapula Consortium |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The North American Scapula Consortium (NASCon) is a multi-center injury specific outcomes
registry.
There currently exists a paucity of outcomes data in the literature on this patient
population. The NASCon registry will be a resource in which investigators can conduct
adequately powered clinical outcomes research resulting in higher quality research with
meaningful results, improved patient care, and evidence-based advancement for the treatment
of scapula fractures. Registries can lead to significant discoveries in comparative
effectiveness specifically in areas where randomized control studies are not possible.
Collecting post-treatment (operative and non-operative) patient outcome data for similar
injury patterns has been shown effective in uncovering optimal standards for treatment.
Description:
Number of Subjects:
Estimated
Year 1 10 Sites 80 Subjects Enrolled
Year 2 13 Sites 130 Subjects Enrolled
Year 3 16 Sites 170 Subjects Enrolled
Year 4 and on going 200 Subjects per year
The North American Scapula Consortium, NASCon is a multi center injury specific outcomes
registry. Patients presenting to participating surgeons with Extra Articular and/or Intra
Articular scapula fracture meeting inclusion criteria will be asked for their signed consent
to participate in the outcomes registry regardless of treatment plan (operative or
non-operative).
Justification for stated number of subjects:
The goal of this study is to capture as many patients meeting inclusion criteria from the
enrolling sites as possible. The investigators estimate this to be between 10 and 13
patients per site, per year.
Participating sites: Participating sites will be identified based on their experience and
expertise in scapula repair, their interest in research, and their desire to advance
knowledge and continuing education in this area. Initially, Dr. Peter Cole will personally
invite new sites. Future site recruitment will be approved by Dr. Peter Cole and a selected
board. Sites must have the necessary research infrastructure and be willing and able to
follow all rules and regulations associated with Human Research requirements. They will be
required to submit evidence of site IRB approval prior to initiation.
Data Collection:
Time point: Day 0
Activity: obtain patient consent, x-rays, chart review, data pull from electronic medical
record
Activity conducted by: study coordinator at participating NASCon site
Time point: 6 wks , 3 mos, 6 mos, 12 mos, 24 mos
Activity: patient questionnaires, Range of Motion, Strength, and x-rays
The following is a list of demographic and treatment variables that will be collected during
the patient's initial enrollment visit as well as from the patient's EMR:
Demographics: Gender, date of birth, dominant hand
Injury: Inclusion indication, radiographic image, date of injury, mechanism of injury, side
of scapular injury, ipsilateral UE fractures, other SSSC lesions, other system injuries, Ada
& AO/OTA Classifications, prior treatment, and workman's compensation status.
Surgical Data (when applicable): Date of surgery, operative time, estimated blood loss,
other procedures, subsequent shoulder procedures required, scapula operative approach, type
of implant.
The following is a list of outcome variables that will be collected during each follow-up
clinic visit as well as from the patient's EMR:
General Information: Physical Therapy, activity level, return to work, pain/pain medication,
complications, subsequent procedures, radiographic image.
Range of Motion:
A 14 inch goniometer will be used to evaluate flexion, abduction, external rotation,
internal rotation on injured and contralateral shoulder.
Strength:
A handheld dynamometer (MicroFET 2, Hoggan Health Industries, Draper, Utah), which has been
previously published as a reliable technique10, will assess strength in shoulder flexion,
abduction, and external rotation on injured and contralateral shoulder.
Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH). 11
The DASH was developed to measure physical disability and symptoms of the upper extremities
in people with upper extremity disorders (hand, wrist, elbow, and shoulder). It is a 30-item
scale that addresses difficulty in performing various physical activities that require upper
extremity function, stiffness, and impact of disability and symptoms on social activities,
work, sleep, and psychological well-being. The score ranges from 0 to 100, where 0 is
equivalent to no disability and 100 is equivalent to most severe disability. The DASH is a
validated instrument with established normative and minimal clinically important difference.
SF-12v2
The SF-12v2 is a multipurpose, short-form health survey with 12 questions. The SF-12v2 was
developed in 1994 by The Health Institute as a shortened version of the SF-36 health survey.
It yields an eight-scale profile of scores as well as physical and mental health summary
measures. The eight scales include: physical functioning, role of physical functioning,
mental functioning, role of mental functioning, social function, bodily pain, vitality, and
general health. It is a generic measure, as opposed to one that targets a specific age,
disease, or treatment group.
Reporting of Results:
Demographic data, treatment details, and outcome variables will be summarized through
frequencies and proportions, if they are categorical, or through measures of central
tendency (e.g., mean, median) and dispersion (e.g. standard deviation, quartiles) if they
are continuous. Quarterly registry reporting will include enrollment rates, follow-up
capture rates, descriptive summaries of demographic, surgical and outcomes data as well as a
description of any safety events for which the membership or the sponsors should be made
aware. Reports will be shared with the membership and study sponsors on a minimum of an
annual basis.
Publication and presentation of outcomes is expected in peer-reviewed orthopaedic journals
and symposia, once substantial data collection and outcomes of ≥1 year post-injury are
accomplished. Additionally, opportunities to describe the establishment of an injury
specific consortium and registry, including experience, process and tools utilized in the
development of such a registry, may be pursued by the membership.
