- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620892
Study of Patient Outcomes 5 Years After Partial Knee Replacement
January 8, 2019 updated by: Ormonde M. Mahoney, MD, Athens Orthopedic Clinic, P.A.
Outcomes of Patients With Unicompartmental Arthritis of the Knee Five Years After Treatment With Partial Knee Replacement
The study seeks to evaluate the condition of patients 5 years after having undergone partial knee replacement for localized osteoarthritis of the knee.
Participating patients will voluntarily undergo detailed evaluation of clinical and radiologic outcomes 5 years after surgery.
The aims of the study are to describe the survivorship of the prostheses and the clinical results of patients, and to elucidate and describe the natural history disease of the untreated knee joint compartments after a partial replacement.
Patients who were operated by the principal investigator 5 years previously will be invited to participate.
The study is observational in nature; there is no element of experimentation or test of an intervention.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
159
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Athens, Georgia, United States, 30606
- Athens Orthopedic Clinic, P.A.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The potential study population consists of all patients who have undergone implantation of a specific unicondylar knee arthroplasty device under the care of the principal investigator between December, 2006 and December, 2008.
This is a clinic-based sample of consecutive cases.
Description
Inclusion Criteria:
- All individuals who have undergone unicondylar knee replacement of a single tibio-femoral compartment using iBalance prosthesis (Arthrex, Inc, Lakeland Florida) under the care of the principal investigator between December, 2006 and December, 2008 will be invited to participate in the study.
Exclusion Criteria:
- There are no restrictions to inclusion in the study based on surgical or medical criteria; however, individuals who are pregnant, incarcerated, less than 18 years of age, or unable to give valid informed consent on their own behalf will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Unicondylar knee replacement
This is a non-intervational, retrospective, observational study of a case series cohort of patients who received a particular surgical operation during a specified time period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to revision of the partial total knee prosthesis
Time Frame: 5 to 7 years after original implantation
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Eligible participants are invited to enroll into this observational study after the 5-year anniversary of the index primary knee replacement procedure.
The participant will be evaluated once to determine whether the original implant is in situ, or has been revised.
Method of determination will include self-report of the participant, medical records review/verification, and radiographic examination of the prosthesis.
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5 to 7 years after original implantation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ormonde M Mahoney, MD, Athens Orthopedic Clinic, P.A.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
June 13, 2012
First Submitted That Met QC Criteria
June 13, 2012
First Posted (Estimate)
June 15, 2012
Study Record Updates
Last Update Posted (Actual)
January 10, 2019
Last Update Submitted That Met QC Criteria
January 8, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOC-OM-Arthrex-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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