Study of Patient Outcomes 5 Years After Partial Knee Replacement

This study is enrolling participants by invitation only.
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: May 5, 2014
Last verified: May 2014
  Purpose

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
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.:

Primary Outcome Measures:
  • Time to revision of the partial total knee prosthesis [ Time Frame: 5 to 7 years after original implantation ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 185
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Athens Orthopedic Clinic, P.A.
Athens, Georgia, United States, 30606
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: May 5, 2014
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 September 30, 2014