NCT00837772

Brief Summary

Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a MRI generated cutting guide called Otismed. All patients have an MRI so both groups will be unaware of which surgical technique is used. All patients receive the usual pre-op care and same type of replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. Patients will be informed of which surgical technique they were randomized to at the conclusion of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

4.5 years

First QC Date

February 3, 2009

Last Update Submit

April 4, 2016

Conditions

Osteoarthritis of the Knee

Keywords

Alignment

Outcome Measures

Primary Outcomes (1)

  • Patient scores on Oxford, Womac, and Knee Society scores

    4 week, 3 mo. 6 mo. 1 yr. 2 yr.

Secondary Outcomes (1)

  • Leg alignment based on Long Leg CT scans

    Post-op

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Usual standard cutting guide for TKA (Total Knee Arthroscopy)

Device: Standard cutting guide for TKA

Arm 2

EXPERIMENTAL

Otismed MRI generated cutting guide for TKA

Device: Otismed MRI generated cutting guide for TKA

Interventions

Standard cutting guide for TKADEVICE

Use of the usual cutting guide for surgical replacement of a diseased knee

Arm 1
Otismed MRI generated cutting guide for TKADEVICE

Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee

Also known as: Otismed
Arm 2

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Veterans that are referred to orthopedics surgical clinic for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate.

You may not qualify if:

  • Patients who have undergone osteotomy, had previous healed tibia or femur fractures, previous joint replacement surgery or cannot have an MRI will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carl T. Hayden VA Medical Center

Phoenix, Arizona, 85012, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

Related Publications (2)

  • Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.

    PMID: 24986944BACKGROUND

  • Dossett HG, Arthur JR, Makovicka JL, Mara KC, Bingham JS, Clarke HD, Spangehl MJ. A Randomized Controlled Trial of Kinematically and Mechanically Aligned Total Knee Arthroplasties: Long-Term Follow-Up. J Arthroplasty. 2023 Jun;38(6S):S209-S214. doi: 10.1016/j.arth.2023.03.065. Epub 2023 Mar 30.

    PMID: 37003458DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Harold G. Dossett, MD MBA

    Carl T. Hayden VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 5, 2009

Study Start

January 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2014

Last Updated

April 6, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)