Study of Patient Outcomes 5 Years After Partial Knee Replacement

NCT01620892 | Completed

• 1 other identifier: AOC-OM-Arthrex-001
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

unicondylar knee arthroplasty; partial knee replacement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Athens Orthopedic Clinic, P.A.: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Athens Orthopedic Clinic, P.A.

Athens, Georgia, 30606, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ormonde M Mahoney, MD

  Athens Orthopedic Clinic, P.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Orthopedic Surgeon

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (1)