NCT02186587

Brief Summary

To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant. Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom instruments will show faster functional recovery, including gait and patient functional outcome scores, when compared to standard, off-the-shelf total knee components inserted with non-navigated instruments (the present standard of care in total knee surgery).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

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

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 19, 2017

Completed
Last Updated

May 23, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

July 7, 2014

Results QC Date

April 14, 2016

Last Update Submit

April 27, 2023

Conditions

Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (1)

  • Distance Measured During 6-minute Walk Test

    Subjects will walk for 6 minutes and the distance covered will be measured in feet.

    6 months

Study Arms (1)

ConforMIS

OTHER

Subjects who receive a ConforMIS custom total knee implant.

Device: ConforMIS custom total knee

Interventions

ConforMIS custom total kneeDEVICE

Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months

ConforMIS

Eligibility Criteria

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

You may qualify if:

  • \- undergoing total knee arthroplasty

You may not qualify if:

  • \- BMI \>40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

Results Point of Contact

Title
Sonny B. Bal, MD, PI
Organization
University of Missouri - Department of Orthopaedic Surgery
BalB@health.missouri.edu
573-882-6762

Study Officials

  • Sonny Bal, MD

    Professor - PI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 10, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

April 1, 2016

Last Updated

May 23, 2023

Results First Posted

January 19, 2017

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)