NCT02251522

Brief Summary

It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
873

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
2 countries

16 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

First Submitted

Initial submission to the registry

September 22, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

September 22, 2014

Last Update Submit

October 23, 2023

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Functional Outcome time differences between the two groups

    The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants

    at least 6 months post-op

Secondary Outcomes (3)

  • Outcomes questionnaire- Knee Society Score

    At least 6 months post op

  • Outcomes questionnaire- KOOS

    At least 6 months post op

  • Outcomes questionnaire- Forgotten Joint Score

    At least 6 months post op

Study Arms (2)

ConforMIS iTotal Knee Replacement System

Patients who have had an iTotal knee replacement at least 6 months prior to testing

Device: ConforMIS Total Knee Replacement System

Off-the-Shelf Knee Replacement System

Patients who have had an off-the-shelf knee replacement at least 6 months prior to testing

Device: Off-the-Shelf Knee Replacement System

Interventions

ConforMIS Total Knee Replacement SystemDEVICE

Total knee replacement system using a patient specific implant.

ConforMIS iTotal Knee Replacement System
Off-the-Shelf Knee Replacement SystemDEVICE

Total knee replacement system not using a patient specific implant.

Off-the-Shelf Knee Replacement System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include a 1:1 ratio of patients enrolled into both the iTotal arm and the off-the-shelf total knee arm.

You may qualify if:

  • Implant must be at least 6 months post-op and doing well
  • Patient has had a total CR knee implant
  • \> 18 years of age

You may not qualify if:

  • Simultaneous bilateral procedure occurred
  • BMI \> 40
  • Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
  • Participation in another clinical study which would confound results
  • Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Denver-Vail Orthopedics

Parker, Colorado, 80134, United States

Location

Institute for Orthopaedic Surgery & Sports Medicine

Fort Myers, Florida, 33919, United States

Location

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Coastal Orthopaedic & Sports Medicine Ctr

Port Saint Lucie, Florida, 34996, United States

Location

Bethesda Orthopedic

Bethesda, Maryland, 20817, United States

Location

Excel Orthopaedic Specialists

Woburn, Massachusetts, 01801, United States

Location

Great Lakes Bone & Joint Center

Battle Creek, Michigan, 49015, United States

Location

Lederman-Kwartowitz Center for Orthopedics and Sports Medicine

West Bloomfield, Michigan, 48323, United States

Location

Orthopaedic Institute of Henderson

Henderson, Nevada, 89052, United States

Location

St. Lawrence Health System

Potsdam, New York, 13676, United States

Location

Orthopedic Specialties of Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

Advanced Orthopedics & Sports Medicine

Cypress, Texas, 77429, United States

Location

Vitos Orthopädische Klinik Kassel

Kassel, Germany

Location

MedArtes

Neutraubling, Germany

Location

Elblandkliniken Stiftung

Radebeul, Germany

Location

Sportklinik Stuttgart

Stuttgart, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Robert Tait, MD

    Orthopaedic Institute of Henderson

    PRINCIPAL INVESTIGATOR

  • Mary O'Connor, MD

    Yale University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 29, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(12)DE(4)