A Clinical Investigation of the Oxford® Partial Knee System | NCT00699257

Studies
A Clinical Investigation of the Oxford® Partial Knee System

NCT00699257

Sponsor

Biomet Orthopedics, LLC

Status

Terminated

Last Update Posted

Jun 21, 2017Actual

Enrollment

85Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Aug 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 13, 2008

First Posted Date

Jun 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2017

Last Update Posted Date

Jun 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Label	Type	Description	Intervention Names
Oxford® Partial Knee System

Measure	Description	Time Frame
Knee Society Score		6 weeks, 3 months, 1 year, 3 years, 5 years
Oxford-12 Self Assessment Form		6 weeks, 3 months, 1 year, 3 years, 5 years

Measure	Description	Time Frame
Incidence of revisions and removals		Any time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement.

Exclusion Criteria:

Infection
Use in the lateral compartment of the knee
Rheumatoid arthritis or other forms of inflammatory joint disease
Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
Disease or damage to the lateral compartment of the knee
Uncooperative patient or patient with neurologic disorders who is incapable of following directions
Osteoporosis
Metabolic disorders which may impair bone formation
Osteomalacia
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
Vascular insufficiency, muscular atrophy, neuromuscular disease
Incomplete or deficient soft tissue surrounding the knee
Charcot's disease
A fixed varus deformity (not passively correctable) of greater than 15 degrees
A flexion deformity greater than 15 degrees

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients that have already made the decision to undergo knee surgery and will receive the Oxford® Partial Knee System.

Sampling Method

Non-Probability Sample

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases