Oxford Partial Knee Comparative Instrument Pilot Study

A Comparison of Signature Guides and Conventional Instrumentation With the Oxford Partial Knee System Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Conventional Instrumentation; Procedure: Signature Custom Guides

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand
    • Leinster Orthopaedic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• The exclusion criteria will include the same contraindications stated in the FDA approved labeling for the device (approved in PMA P010014). These contraindications include:
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Oxford instrumentation; Patients who receive an Oxford Partial Knee with Conventional instrumentation.	Procedure: Conventional Instrumentation; Standard Oxford surgical instruments
Experimental: Signature Guides Oxford; Patients who receive an Oxford Partial Knee with Signature Custom Guides	Procedure: Signature Custom Guides; Signature Custom Guides used with Instruments in surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Knee Score	The Oxford Knee Score is a patient administered questionnaire about how they are functioning and feel about their knee.	Two Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Operative Time	From incision to incision closure.	1 Year

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Rod Maxwell, Canterbury Orthopaedic Services

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: August 4, 2011
• First Posted (Estimate): August 5, 2011

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ORTHO.CR.GK1 (407)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO