Study of Patient Outcomes 5 Years After Partial Knee Replacement

This study is not yet open for participant recruitment.
Verified June 2012 by Athens Orthopedic Clinic, P.A.
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Athens Orthopedic Clinic, P.A.
ClinicalTrials.gov Identifier:
NCT01620892
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

The study seeks to evaluate the condition of patients 5 years after 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
Osteoarthritis, Knee

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Athens Orthopedic Clinic, P.A.:

Estimated Enrollment: 185
Study Start Date: June 2012
Groups/Cohorts
Unicondylar knee replacement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620892

Contacts
Contact: Tracy L Kinsey, MSPH 706-549-1663 ext 3275 tracy@aocfoundation.org
Contact: Megan Johnson 706-549-1663 ext 3275 megan@aocfoundation.org

Locations
United States, Georgia
Athens Orthopedic Clinic, P.A. Not yet recruiting
Athens, Georgia, United States, 30606
Contact: Tracy L Kinsey, MSPH         tracy@aocfoundation.org    
Contact: Ormonde M Mahoney, MD         mahoney@aocfoundation.org    
Principal Investigator: Ormonde M Mahoney, MD            
Sub-Investigator: Tracy L Kinsey, MSPH            
Sponsors and Collaborators
Athens Orthopedic Clinic, P.A.
Arthrex, Inc.
Investigators
Principal Investigator: Ormonde M Mahoney, MD Athens Orthopedic Clinic, P.A.
  More Information

No publications provided

Responsible Party: Athens Orthopedic Clinic, P.A.
ClinicalTrials.gov Identifier: NCT01620892     History of Changes
Other Study ID Numbers: AOC-OM-Arthrex-001
Study First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013