NCT02494544

Brief Summary

Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

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

First Submitted

Initial submission to the registry

May 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2022

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

October 8, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

7.4 years

First QC Date

May 28, 2015

Results QC Date

August 22, 2025

Last Update Submit

November 10, 2025

Conditions

Osteoarthritis

Keywords

knee implantknee replacementtotal knee replacement

Outcome Measures

Primary Outcomes (1)

  • Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure

    Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function.

    1 year

Secondary Outcomes (2)

  • Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure

    1 year

  • Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates)

    1 year

Study Arms (6)

ConforMIS iTotal Knee replacement

ACTIVE COMPARATOR

iTotal patient-specific knee replacement system

Device: ConforMIS iTotal Knee Replacement

DePuy total knee replacement

ACTIVE COMPARATOR

Off the shelf knee replacement system

Device: Off the Shelf Total Knee Replacement

Zimmer total knee replacement

ACTIVE COMPARATOR

Off the shelf knee replacement system

Device: Off the Shelf Total Knee Replacement

Biomet total knee replacement

ACTIVE COMPARATOR

Off the shelf knee replacement system

Device: Off the Shelf Total Knee Replacement

Smith & Nephew total knee replacement

ACTIVE COMPARATOR

Off the shelf knee replacement system

Device: Off the Shelf Total Knee Replacement

Stryker total knee replacement

ACTIVE COMPARATOR

Off the shelf knee replacement system

Device: Off the Shelf Total Knee Replacement

Interventions

Off the Shelf Total Knee ReplacementDEVICE

A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker

Biomet total knee replacementDePuy total knee replacementSmith & Nephew total knee replacementStryker total knee replacementZimmer total knee replacement
ConforMIS iTotal Knee ReplacementDEVICE

A knee replacement performed with patient specific implant and surgical jigs.

ConforMIS iTotal Knee replacement

Eligibility Criteria

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

You may qualify if:

  • Clinical condition included in the approved Indications For Use for the iTotal CR
  • Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment
  • Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
  • \> 18 years of age

You may not qualify if:

  • Subject will require a simultaneous bilateral procedure
  • Other lower extremity surgery within 1 year
  • Severe (\> 15º) fixed valgus or varus deformity
  • Severe (\> 15º) extension deficit
  • Severe instability due to advanced loss of osteochondral structure
  • Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified
  • Insufficient bone stock on the femoral or tibial surfaces
  • Contralateral knee replacement surgery within the past 6 months
  • BMI \> 40
  • Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
  • Poorly controlled diabetes (defined as HbA1c \>7 or surgeon discretion)
  • Immunocompromised
  • Other physical disability affecting the hips, spine, or contralateral knee that limits function
  • Disabling chronic pain with narcotic dependence
  • Compromised PCL or collateral ligament
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California in San Diego

La Jolla, California, 92037, United States

Location

Sharp Healthcare

San Diego, California, 92123, United States

Location

Denver-Vail Orthopedics

Parker, Colorado, 80134, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Tufts University

Boston, Massachusetts, 02111, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

OrthoNY

Albany, New York, 12205, United States

Location

The Lindner Center for Research and Education

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Tara Mann - Director of Clinical Affairs
Organization
restor3d
clinicalresearch@restor3d.com
(984) 888-0593

Study Officials

  • Mary O'Connor, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Site staff that is performing functional testing on subject is blinded to what implant the patient has.
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

July 10, 2015

Study Start

July 1, 2015

Primary Completion

November 16, 2022

Study Completion

November 16, 2022

Last Updated

November 21, 2025

Results First Posted

October 8, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(8)