Study of Patient Outcomes 5 Years After Partial Knee Replacement

NCT ID: NCT01620892

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthrex, Inc.

INDUSTRY

Sponsor Role collaborator

Athens Orthopedic Clinic, P.A.

OTHER

Sponsor Role lead

Responsible Party

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Ormonde M. Mahoney, MD

Principal Investigator, Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ormonde M Mahoney, MD

Role: PRINCIPAL_INVESTIGATOR

Athens Orthopedic Clinic, P.A.

Locations

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Athens Orthopedic Clinic, P.A.

Athens, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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AOC-OM-Arthrex-001

Identifier Type: -

Identifier Source: org_study_id

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