NCT01410786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

July 14, 2011

Last Update Submit

August 1, 2017

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Average Operative Time

    1 Year

Study Arms (2)

Conventional Oxford instrumentation

ACTIVE COMPARATOR

Patients who receive an Oxford Partial Knee with Conventional instrumentation.

Procedure: Conventional Instrumentation

Signature Guides Oxford

EXPERIMENTAL

Patients who receive an Oxford Partial Knee with Signature Custom Guides

Procedure: Signature Custom Guides

Interventions

Conventional InstrumentationPROCEDURE

Standard Oxford surgical instruments

Conventional Oxford instrumentation
Signature Custom GuidesPROCEDURE

Signature Custom Guides used with Instruments in surgical technique

Signature Guides Oxford

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leinster Orthopaedic Centre

Christchurch, New Zealand

Location

Related Publications (2)

  • 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.

    PMID: 2805470BACKGROUND

  • 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.

    PMID: 9460955BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Rod Maxwell

    Canterbury Orthopaedic Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

August 5, 2011

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

August 2, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)