NCT01132365

Brief Summary

Objective Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes. Examine the relationship between processes of care, hospital and surgeon associated outcomes. Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients. Analyze and design ancillary studies to address unanswered questions. Disseminate findings through publication in peer-reviewed scientific journals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7,793

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

April 1, 2005

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

13.7 years

First QC Date

May 26, 2010

Last Update Submit

July 22, 2016

Conditions

Keywords

knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Knee Society Score

    2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years

Study Arms (1)

knee arthroplasty

Device: any knee joint arthroplasty device

Interventions

Cohort consist of all consented patients receiving knee arthroplasty

Also known as: Total Knee Arthoplasty, Unicondylar Knee arthroplasty, Revision Knee Arthroplasty
knee arthroplasty

Eligibility Criteria

Age21 Years - 93 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All male and non-pregnant females undergoing knee arthroplasty.

You may qualify if:

  • Patient is a male or non-pregnant female over the age of 21.
  • Patient requires a knee arthroplasty, revision knee arthroplasty, or unicondylar knee arthroplasty
  • Patient has signed and dated an IRB approved consent form.
  • Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
  • Patient has failed to respond to conservative treatment modalities.

You may not qualify if:

  • Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
  • Patient is a prisoner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heekin Orthopedic Specialists

Jacksonville, Florida, 32204, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Richard D Heekin, MD

    Heekin Orthopedic Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
R. David Heekin, M.D.

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 28, 2010

Study Start

April 1, 2005

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations