NCT00492219

Brief Summary

The purpose of this study is to determine if patients with a fixed-bearing or mobile-bearing partial knee replacement perform functional activities differently than patients that have had total knee replacement or healthy volunteers that have not had knee surgery. The activities we are interested in include getting up out of a chair, stepping up and over a small wooden box, and standing still with the knees straight and also bent to 45 degrees.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 19, 2012

Status Verified

June 1, 2007

Enrollment Period

1.2 years

First QC Date

June 25, 2007

Last Update Submit

October 18, 2012

Conditions

OsteoarthritisPost-traumatic Arthritis

Keywords

arthroplastyreplacementkneeprosthesis

Outcome Measures

Primary Outcomes (5)

  • Performance of three functional tests on a force platform

    Baseline (preoperative), 6 weeks, 3 months, and 1, 2, and 5 years postoperative

  • Knee Society Scores

    Baseline (preoperative), and 6 weeks, 3 months, and 1, 2, and 5 years after surgery

  • Patient Satisfaction

    6 weeks, 3 months, and 1, 2, and 5 years after surgery

  • Any postoperative complications

    6 weeks, 3 months, and 1, 2, and 5 years after surgery

  • Radiographic signs of component loosening or change of position, as well as progression of arthritis in the lateral compartment for the partial knee replacement patients

    6 weeks and 1, 2, and 5 years postoperative

Study Arms (4)

1

ACTIVE COMPARATOR

Patients undergoing total knee replacement

Device: Total Knee Replacement

2

NO INTERVENTION

Healthy volunteers that are not undergoing knee replacement surgery

3

EXPERIMENTAL

Patients undergoing partial knee replacement with the Oxford mobile bearing implant system

Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses

4

EXPERIMENTAL

Patients undergoing partial knee replacement with the Vanguard M implant system

Device: Vanguard M fixed-bearing or Oxford mobile-bearing prostheses

Interventions

Vanguard M fixed-bearing or Oxford mobile-bearing prosthesesDEVICE

Patients that are appropriate for partial knee replacement will be randomized to receive one of these two FDA-approved implant systems.

Also known as: All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.
34
Total Knee ReplacementDEVICE

Patients undergoing total knee replacement with the Vanguard Complete Knee implant system

Also known as: All implant systems associated with this study are manufactured by Biomet, Inc. in Warsaw, IN.
1

Eligibility Criteria

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

You may qualify if:

  • Patients that have elected to undergo either partial or total knee replacement, as well as a control group of patients free of lower extremity pathology

You may not qualify if:

  • Sensory, neurological, or general health conditions that alter perception of the patient's limb in space
  • Vestibular disorders will be excluded in order to protect against falls during functional testing
  • Unable to understand the questions used to obtain the Knee Society Score
  • Minors and prisoners will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexington Clinic Sports Medicine Center

Lexington, Kentucky, 40504, United States

Location

Related Publications (2)

  • Berend KR, Lombardi AV Jr. Liberal indications for minimally invasive oxford unicondylar arthroplasty provide rapid functional recovery and pain relief. Surg Technol Int. 2007;16:193-7.

    PMID: 17429788BACKGROUND

  • Li MG, Yao F, Joss B, Ioppolo J, Nivbrant B, Wood D. Mobile vs. fixed bearing unicondylar knee arthroplasty: A randomized study on short term clinical outcomes and knee kinematics. Knee. 2006 Oct;13(5):365-70. doi: 10.1016/j.knee.2006.05.003. Epub 2006 Jun 22.

    PMID: 16797994BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Christian P Christensen, MD

    New Lexington Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 19, 2012

Record last verified: 2007-06

Locations

US(1)