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Oxford Partial Knee Comparative Instrument Pilot Study

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Conventional Instrumentation
Signature Custom Guides
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leinster Orthopaedic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Oxford instrumentation

Signature Guides Oxford

Arm Description

Patients who receive an Oxford Partial Knee with Conventional instrumentation.

Patients who receive an Oxford Partial Knee with Signature Custom Guides

Outcomes

Primary Outcome Measures

Oxford Knee Score
The Oxford Knee Score is a patient administered questionnaire about how they are functioning and feel about their knee.

Secondary Outcome Measures

Average Operative Time
From incision to incision closure.

Full Information

First Posted
July 14, 2011
Last Updated
August 1, 2017
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01410786
Brief Title
Oxford Partial Knee Comparative Instrument Pilot Study
Official Title
A Comparison of Signature Guides and Conventional Instrumentation With the Oxford Partial Knee System Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Oxford instrumentation
Arm Type
Active Comparator
Arm Description
Patients who receive an Oxford Partial Knee with Conventional instrumentation.
Arm Title
Signature Guides Oxford
Arm Type
Experimental
Arm Description
Patients who receive an Oxford Partial Knee with Signature Custom Guides
Intervention Type
Procedure
Intervention Name(s)
Conventional Instrumentation
Intervention Description
Standard Oxford surgical instruments
Intervention Type
Procedure
Intervention Name(s)
Signature Custom Guides
Intervention Description
Signature Custom Guides used with Instruments in surgical technique
Primary Outcome Measure Information:
Title
Oxford Knee Score
Description
The Oxford Knee Score is a patient administered questionnaire about how they are functioning and feel about their knee.
Time Frame
Two Years
Secondary Outcome Measure Information:
Title
Average Operative Time
Description
From incision to incision closure.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rod Maxwell
Organizational Affiliation
Canterbury Orthopaedic Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leinster Orthopaedic Centre
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2805470
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.
Results Reference
background
PubMed Identifier
9460955
Citation
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.
Results Reference
background

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Oxford Partial Knee Comparative Instrument Pilot Study

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