Oxford Partial Knee Comparative Instrument Pilot Study

NCT ID: NCT01410786

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumentation.

Detailed Description

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumentation.

The FDA has approved the Oxford Partial Knee via Premarket Approval P010014. Also, by being CE marked, the Oxford Partial Knee also conforms to the essential requirements of EC Directive 93/42/EEC; in accordance to 13485:2003. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.

Surgical techniques and patient care are to be standard for the surgeon participating in the protocol for both treatment groups and should be maintained the same throughout the course of the data-collection. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling. Any use of the device or collection of clinical data outside of the United States should comply with all local, state, and/or national and international regulations.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Conventional Oxford instrumentation

Patients who receive an Oxford Partial Knee with Conventional instrumentation.

Group Type: ACTIVE_COMPARATOR

Conventional Instrumentation

Intervention Type: PROCEDURE

Standard Oxford surgical instruments

Signature Guides Oxford

Patients who receive an Oxford Partial Knee with Signature Custom Guides

Group Type: EXPERIMENTAL

Signature Custom Guides

Intervention Type: PROCEDURE

Signature Custom Guides used with Instruments in surgical technique

Interventions

Conventional Instrumentation

Standard Oxford surgical instruments

Intervention Type: PROCEDURE

Signature Custom Guides

Signature Custom Guides used with Instruments in surgical technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Outside the United States:

-The Oxford Partial 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 (in the United States). Use of cementless femoral fixation is permitted outside of the United States only (if it complies with all local, state, and/or national and international regulations), however the same technique must be used consistently throughout the course of the study (cemented or cementless).

Exclusion Criteria

• Infection, sepsis, and osteomyelitis
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rod Maxwell

Role: PRINCIPAL_INVESTIGATOR

Canterbury Orthopaedic Services

Locations

Leinster Orthopaedic Centre

Christchurch, , New Zealand

Countries

New Zealand

References

Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.

Reference Type: BACKGROUND

PMID: 2805470 (View on PubMed)

Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859.

Reference Type: BACKGROUND

PMID: 9460955 (View on PubMed)

Other Identifiers

ORTHO.CR.GK1 (407)

Identifier Type: -

Identifier Source: org_study_id