NCT02692092

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
794mo left

Started Sep 1991

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Sep 1991Aug 2091

Study Start

First participant enrolled

September 1, 1991

Completed
22.4 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
75.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2091

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2091

Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

100 years

First QC Date

January 29, 2014

Last Update Submit

February 23, 2018

Conditions

Bone Fracture

Keywords

ComplicationsArthroplasty, Hip ReplacementArthroplasty, Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Total Arthroplasty Patients

Any patient who has received a total hip or total knee arthroplasty at a healtheast acute care hospital.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having total hip or knee arthroplasty at a HealthEast acute care hospital.

You may qualify if:

  • Total Hip or Total Knee Arthroplasty
  • HealthEast acute care hospital

You may not qualify if:

  • Age\<18
  • Primary procedure not performed at a HealthEast hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthEast Care System

Saint Paul, Minnesota, 55104, United States

RECRUITING

Related Publications (6)

  • 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. doi: 10.1097/BLO.0b013e31812f7879.

    PMID: 17589363RESULT

  • 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. doi: 10.2106/JBJS.E.01198. No abstract available.

    PMID: 16757777RESULT

  • 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.

    PMID: 15534527RESULT

  • 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. doi: 10.1097/01.blo.0000093004.90435.d1.

    PMID: 14646749RESULT

  • 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.

    PMID: 21858641RESULT

  • 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.

    PMID: 20568026RESULT

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Terence J Gioe, MD

    HealthEast Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Killeen

CONTACT

651-232-3191kkilleen@healtheast.org

Susan C Mehle

CONTACT

6512325021smehle@healtheast.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
40 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 25, 2016

Study Start

September 1, 1991

Primary Completion (Estimated)

August 1, 2091

Study Completion (Estimated)

August 1, 2091

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)