Clinical trial NCT00578994: A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
Official title: A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Avascular Necrosis
Keywords: Unicompartmental Knee
Partial Knee
Knee arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A Multi-center study conducted in the United States of patients who meet the FDA approved indications for use. The Oxford Meniscal Unicompartmental Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement.

Brief summary: The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.

Detailed description: Study Objective

To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.

Study Design

The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:

1. A complications study where patients will be followed for at least 2 years to record all complications that may occur, and
2. A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.

Phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data.

Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.

Eligibility criteria: Inclusion Criteria:

* Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis

Exclusion Criteria:

* Patients with Rheumatoid arthritis or other forms of inflammatory joint disease
* Patients with infection, sepsis, and osteomyelitis
* Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis

Primary outcomes:
measure: Survivorship
timeFrame: Annually for 9 years post-op
Secondary outcomes:
measure: Complications
timeFrame: 2 Years
Other outcomes:
Locations:
city: Schaumburg
country: United States
facility: Barrington Orthopedic Specialissts
state: Illinois
city: New Albany
country: United States
facility: Joint Implant Surgeons
state: Ohio
city: Cordova
country: United States
facility: Mid-South Orthopedic Associates
state: Tennessee
city: Bedford
country: United States
facility: Texas Orthopedic Specialist
state: Texas
city: Plano
country: United States
facility: Texas Center for Joint Replacement
state: Texas
city: Richmond
country: United States
facility: Advanced Orthopaedic Centers
state: Virginia
Study officials:
affiliation: kacy.arnold@zimmerbiomet.com
name: Kacy Arnold
role: STUDY_DIRECTOR
References: