Oxford Partial Knee Comparative Instrument Pilot Study

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410786
• Other study ID #: ORTHO.CR.GK1 (407)
• Status: Completed
• Phase: N/A
• First received: July 14, 2011
• Last updated: August 1, 2017
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Conventional Instrumentation
Standard Oxford surgical instruments
• Signature Custom Guides
Signature Custom Guides used with Instruments in surgical technique

Locations

Country	Name	City	State
New Zealand	Leinster Orthopaedic Centre	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

New Zealand, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average Operative Time	From incision to incision closure.	1 Year