North American Scapula Consortium

NCT02993848 | Unknown

• 1 other identifier: CON48716
• Study Type: observational
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Scapular Fracture

Keywords

Scapula; Fracture

Outcome Measures

Primary Outcomes (1)

• Data Submission measured by total number of participating sites and patient enrollment

  Anticipated: Year 1 - 10 Sites,80 Subjects Enrolled Year 2 - 13 Sites, 130 Subjects Enrolled Year 3 - 16 Sites, 170 Subjects Enrolled

  Three years

Secondary Outcomes (1)

• Optimization of data submission and data collected by statistician review of exported data collection

  Biannual review (June 2017, Dec 2017, June 2018, Dec 2018, June 2019, Dec 2019-end date)

Study Arms (2)

Operative Scapula Fracture

No intervention. Inclusion criteria and data collection is the same for both cohort.

Other: No intervention

Non-Operative Scapula Fracture

No intervention. Inclusion criteria and data collection is the same for both cohort.

Other: No intervention

Interventions

No intervention OTHER

Non-Operative Scapula Fracture; Operative Scapula Fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The NASCon registry will include all qualifying, consented scapula fracture patients who present to the participating site PI's clinics or practices for treatment of a scapula fracture. All site PIs will use the same standardized measurement tools (Glenopolar angle, Medialization, and Angulation) to evaluate participants.

You may qualify if:

• ≥18 yrs of age
• Operative and non-operative fractures meeting any one of the following criteria:
• Extra - Articular fracture indication (one or more of the following): Glenopolar angle \<30°, Medialization \>1cm, and Angulation \>30°
• Intra-Articular fracture indication: \>2mm
• Patient signed consent

You may not qualify if:

• Patients meeting operative criteria that are not able to understand the consent for research

Sponsors & Collaborators

• North American Scapula Consortium: lead
• DePuy Synthes: collaborator
• Oregon Health and Science University: collaborator
• University of Minnesota: collaborator

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Peter A Cole, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Orthopaedic Dept., Regions Hospital; Professor, University of Minnesota

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share