Study of Patient Outcomes 5 Years After Partial Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01620892
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : December 19, 2017
Arthrex, Inc.
Information provided by (Responsible Party):
Ormonde M. Mahoney, MD, Athens Orthopedic Clinic, P.A.

Brief Summary:
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.

Condition or disease
Osteoarthritis, Knee

Study Type : Observational
Actual Enrollment : 159 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Outcomes of Patients With Unicompartmental Arthritis of the Knee Five Years After Treatment With Partial Knee Replacement
Study Start Date : June 2012
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Unicondylar knee replacement

Primary Outcome Measures :
  1. Time to revision of the partial total knee prosthesis [ Time Frame: 5 to 7 years after original implantation ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01620892

United States, Georgia
Athens Orthopedic Clinic, P.A.
Athens, Georgia, United States, 30606
Sponsors and Collaborators
Athens Orthopedic Clinic, P.A.
Arthrex, Inc.
Principal Investigator: Ormonde M Mahoney, MD Athens Orthopedic Clinic, P.A.

Responsible Party: Ormonde M. Mahoney, MD, Principal Investigator, Orthopedic Surgeon, Athens Orthopedic Clinic, P.A. Identifier: NCT01620892     History of Changes
Other Study ID Numbers: AOC-OM-Arthrex-001
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by Ormonde M. Mahoney, MD, Athens Orthopedic Clinic, P.A.:
unicondylar knee arthroplasty
partial knee replacement

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases