Study of Patient Outcomes 5 Years After Partial Knee Replacement

Osteoarthritis, Knee Clinical Trial

Official title:

Outcomes of Patients With Unicompartmental Arthritis of the Knee Five Years After Treatment With Partial Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620892
• Other study ID #: AOC-OM-Arthrex-001
• Status: Completed
• Start date: June 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2019
• Source: Athens Orthopedic Clinic, P.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
United States	Athens Orthopedic Clinic, P.A.	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Athens Orthopedic Clinic, P.A.	Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to revision of the partial total knee prosthesis	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.	5 to 7 years after original implantation