HealthEast Community Hip and Knee Replacement Registry

Bone Fracture Clinical Trial

— HEJR  

Official title:

HealthEast Community Hip and Knee Replacement Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02692092
• Other study ID #: 03 12 007R
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2014
• Last updated: February 23, 2018
• Start date: September 1991
• Est. completion date: August 2091

Study information

• Verified date: February 2018
• Source: HealthEast Care System
• Contact: Kathy Killeen
• Phone: 651-232-3191
• Email: kkilleen[@]healtheast.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

HealthEast Care System began the first community-based joint replacement registry (HJRR) in the U.S. in 1991, and now has more than 30,000 total joints registered. The purpose of the HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery by providing timely information to their surgeons and the broader orthopaedic community.

As it moves into the third decade, the HJRR is proud of its role in the development of the national American Joint Replacement Registry (AJRR) and will remain an important contributor to the larger national effort in the advancement of orthopaedic science.

Description:

HealthEast Care System began the first community-based joint replacement registry (HJRR) in the U.S. in 1991, with a database that allowed tracking of implant use and failure rates among the 90 orthopaedic surgeons performing arthroplasty surgery in the greater metropolitan area of St. Paul, MN. Initially conceived as part of a process to better manage costs and determine which implants were most cost-efficient, it became apparent that the registry would allow insight into the same process that had proven its value in the Scandinavian joint registries. With the knowledge that a majority of total joint arthroplasties in the U.S. are performed by relatively low-volume community surgeons, the HJRR remains uniquely positioned to reflect contemporary U.S. surgical practices.

The purpose of the HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery by providing timely information to their surgeons and the broader orthopaedic community. With the primary outcome measure of time to revision surgery, combined with analysis of confounding factors and mortality monitoring, the HJRR can provide some realistic measure of the success of a given arthroplasty procedure in our community. In addition, the registry can evaluate the relative effectiveness of different prosthetic designs, identify patient variables that may impact implant survival, and provide the tracking mechanism necessary in the event of implant recalls.

Over the 20 years of its existence, the HJRR has refined its data-gathering, data verification, and data analysis and utilizes a process design that requires no direct surgeon involvement with data input. Volunteer surgeons review each revision chart and operative note to carefully delineate the reason for revision. The HJRR capture process has been validated and more than 94% of the revision surgery is performed within the HJRR. The database is used to generate information of practical use to the surgeon, and has been demonstrated to influence surgeon behavior. Among other examples, HJRR reports on the failure rates associated with unicompartmental knee arthroplasty, hybrid and cementless total knee arthroplasty, and metal-on-metal total hip designs have led to significant declines in their respective use over the periods documented. Similarly, the HJRR allowed for rapid notification of surgeons and expedited patient care during the three significant hip implant recalls of the last decade.

As it moves into the third decade, the HJRR is proud of its influential role in the development of the national American Joint Replacement Registry (AJRR) as one of the earliest participants and pilot hospitals. It will remain an important contributor to the larger national effort, particularly for certain data subsets that may be outside of the scope of the much larger AJRR. The HJRR core workgroup has published widely on its findings in the last two decades, and looks forward to the future as a compelling example of how worthwhile information and advancements in orthopaedic science can be made in the community setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: August 2091
• Est. primary completion date: August 2091
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Total Hip or Total Knee Arthroplasty

• HealthEast acute care hospital

Exclusion Criteria:

• Age<18

• Primary procedure not performed at a HealthEast hospital

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone

Locations

Country	Name	City	State
United States	HealthEast Care System	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthEast Care System

Country where clinical trial is conducted

United States, 

References & Publications (6)

Gioe TJ, Killeen KK, Grimm K, Mehle S, Scheltema K. Why are total knee replacements revised?: analysis of early revision in a community knee implant registry. Clin Orthop Relat Res. 2004 Nov;(428):100-6. — View Citation

Gioe TJ, Killeen KK, Hoeffel DP, Bert JM, Comfort TK, Scheltema K, Mehle S, Grimm K. Analysis of unicompartmental knee arthroplasty in a community-based implant registry. Clin Orthop Relat Res. 2003 Nov;(416):111-9. — View Citation

Gioe TJ, Killeen KK, Mehle S, Grimm K. Implementation and application of a community total joint registry: a twelve-year history. J Bone Joint Surg Am. 2006 Jun;88(6):1399-404. — View Citation

Gioe TJ, Sharma A, Tatman P, Mehle S. Do "premium" joint implants add value?: analysis of high cost joint implants in a community registry. Clin Orthop Relat Res. 2011 Jan;469(1):48-54. doi: 10.1007/s11999-010-1436-z. — View Citation

Gioe TJ, Sinner P, Mehle S, Ma W, Killeen KK. Excellent survival of all-polyethylene tibial components in a community joint registry. Clin Orthop Relat Res. 2007 Nov;464:88-92. — View Citation

Johnson TC, Tatman PJ, Mehle S, Gioe TJ. Revision surgery for patellofemoral problems: should we always resurface? Clin Orthop Relat Res. 2012 Jan;470(1):211-9. doi: 10.1007/s11999-011-2036-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Revision Rate	Our end point of interest was revision for any reason, with revision defined as removal, exchange, or addition of components, requiring a second surgery.	10 Years