Bone FractureHEJRNCT02692092
HealthEast Community Hip and Knee Replacement Registry
An observational study of Bone Fracture, run by HealthEast Care System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Fracture
- How many people
- 200,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1991to Aug 2091
- How long will I take part?
- 40 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients having total hip or knee arthroplasty at a HealthEast acute care hospital.
Who may be able to join
- Total Hip or Total Knee Arthroplasty
- HealthEast acute care hospital
Who cannot join
- Age<18
- Primary procedure not performed at a HealthEast hospital
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HealthEast Care System
Saint Paul, Minnesota, 55104
Kathy Killeen, 651-232-3191, kkilleen@healtheast.org
Susan C Mehle, 6512325021, smehle@healtheast.org
About this study
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.
Read the detailed 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.
- Conditions
- Bone Fracture
- Keywords
- Complications, Arthroplasty, Hip Replacement, Arthroplasty, Knee Replacement
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Arthroplasty Patients | Any patient who has received a total hip or total knee arthroplasty at a healtheast acute care hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startSep 1991
- Primary completionAug 2091 (estimated)
- Study completionAug 2091 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
- Target duration
- 40 Years
Sponsor and investigators
- Lead sponsor
- HealthEast Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terence J Gioe, MD, Principal investigator, HealthEast Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692092
- Sponsor's protocol ID
- 03 12 007R
- Acronym
- HEJR
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2014
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17589363Gioe 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.
PubMed 16757777Gioe 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.
PubMed 15534527Gioe 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.
PubMed 14646749Johnson 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.
PubMed 21858641Gioe 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.
PubMed 20568026
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthEast Community Hip and Knee Replacement Registry
- ClinicalTrials.gov ID
- NCT02692092
- Acronym / sponsor ID
- HEJR / 03 12 007R
- Conditions
- Bone Fracture
- Keywords
- Complications, Arthroplasty, Hip Replacement, Arthroplasty, Knee Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- HealthEast Care SystemUniversity, hospital or other
- Study start
- Sep 1991
- Primary completion
- Aug 2091 (estimated)
- Study completion
- Aug 2091 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 40 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Arthroplasty Patients | – | –Any patient who has received a total hip or total knee arthroplasty at a healtheast acute care hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having total hip or knee arthroplasty at a HealthEast acute care hospital.
Key inclusion criteria (2 listed)
- Total Hip or Total Knee Arthroplasty
- HealthEast acute care hospital
Key exclusion criteria (2 listed)
- Age<18
- Primary procedure not performed at a HealthEast hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative Revision Rate
Time frame: 10 Years
Our end point of interest was revision for any reason, with revision defined as removal, exchange, or addition of components, requiring a second surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Results publication: PubMed 17589363Gioe 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.
- Results publication: PubMed 16757777Gioe 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.
- Results publication: PubMed 15534527Gioe 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.
- Results publication: PubMed 14646749Gioe 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.
- Results publication: PubMed 21858641Johnson 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.
- Results publication: PubMed 20568026Gioe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terence J Gioe, MD principal investigator
HealthEast Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Fracture, run by HealthEast Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathy Killeen (651-232-3191, kkilleen@healtheast.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Revision Rate (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692092, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.