NCT01242085

Brief Summary

The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2010

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

Study Start

First participant enrolled

November 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 8, 2013

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

1.5 years

First QC Date

November 15, 2010

Results QC Date

February 19, 2013

Last Update Submit

May 9, 2013

Conditions

Knee Arthritis

Keywords

alignment

Outcome Measures

Primary Outcomes (1)

  • Alignment of Knee - Measured Mechanical Axis From CT Data

    the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment

    postoperatively - CT done within 1 week of surgery

Secondary Outcomes (1)

  • Surgical Time

    intraoperative surgical time

Study Arms (2)

control group

ACTIVE COMPARATOR

control group will have standard instrumentation of their knee replacement

Procedure: control group

trumatch group

EXPERIMENTAL

the trumatch patient will have custom instruments made from preop CT scans

Procedure: trumatch group

Interventions

trumatch groupPROCEDURE

these patient will have CT based customized knee instruments used for surgery

Also known as: trumatch CPI
trumatch group
control groupPROCEDURE

these patients will have standard instrumentation used for for knee replacement

Also known as: Depuy knee instruments
control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto VA HCS

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Limitations and Caveats

none except small sample sizes

Results Point of Contact

Title
Steven T Woolson, MD
Organization
VA Palo Alto HCS
steven.woolson@va.gov
650-493-5000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
staff surgeon

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2012

Study Completion

January 1, 2013

Last Updated

May 14, 2013

Results First Posted

May 8, 2013

Record last verified: 2013-05

Locations

US(1)