NCT01454908

Brief Summary

The objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2006

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

6.3 years

First QC Date

October 13, 2011

Last Update Submit

October 18, 2011

Conditions

Medial Knee Compartment Arthritis

Keywords

partial knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Knee Society Score (KSS)

    up to 1 month pre-operatively and at 1 year post operatively

Secondary Outcomes (1)

  • Range of Motion (ROM)

    up to 1 month pre-operatively and at 1 year post operatively

Study Arms (1)

Partial Knee Arthroplasty

OTHER

Oxford Mobile Bearing Unicompartmental Knee Arthroplasties

Device: Oxford Partial Knee

Interventions

Oxford Partial KneeDEVICE

The Oxford partial knee contains tibial and medial components and a mobile meniscal bearing.

Partial Knee Arthroplasty

Eligibility Criteria

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

You may qualify if:

  • Patients with medial knee compartment arthritis

You may not qualify if:

  • Patients with diagnoses other than osteoarthritis (i.e., rheumatoid arthritis, psoriatic arthritis, etc.)
  • Patients with significant diseases of other joints of the lower extremity
  • Patients with a diagnosed disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnosed movement disorders, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SHRI-CORE Orthopedic Research Lab

Sun City West, Arizona, 85375, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 19, 2011

Study Start

April 1, 2006

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

October 19, 2011

Record last verified: 2011-10

Locations

US(1)