NCT01564641

Brief Summary

To evaluate the ConforMIS iDuo G2 implant

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

3 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

March 12, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2022

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

4.3 years

First QC Date

March 12, 2012

Last Update Submit

October 23, 2023

Conditions

Bicompartmental Osteoarthritis

Keywords

kneeosteoarthritisbicompartmentalarthroplastyjoint diseases

Outcome Measures

Primary Outcomes (1)

  • Pain and function

    By using questionnaires, we will look at pain and function scores at this time point

    3 months

Secondary Outcomes (10)

  • Pain and function at follow up time points

    1, 2, 5 and 10 years post implant

  • Revision rates

    Patient will be observed for 10 years post implant

  • Incidence of major procedure related and device related complications

    Patient will be observed for 10 years post implant

  • Post operative limb alignment

    X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups

  • Radiographic implant position

    X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups

  • +5 more secondary outcomes

Study Arms (1)

iDuo G2

iDuo G2 to be implanted in the patient.

Device: iDuo G2

Interventions

iDuo G2DEVICE

single comparator

iDuo G2

Eligibility Criteria

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

Patients presenting this specific form of osteoarthritis at participating sites with IRB approval.

You may qualify if:

  • Clinical condition included in the approved Indications For Use for the iDuo® G2
  • Bicompartmental osteoarthritis defined as Medial and patellofemoral osteoarthritis, or Lateral and patellofemoral arthritis as confirmed by the investigator's assessment of disease status at screening visit. Disease status is assessed by Clinical and Radiographic assessment. In addition, CT arthrogram assessment may be utilized for diagnosis.
  • 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:

  • 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
  • Neuromuscular conditions which prevent patient from participating in study activities
  • Active local or systemic infection
  • Immunocompromised
  • Fibromyalgia or other general body pain related condition
  • Rheumatoid arthritis or other forms of inflammatory joint disease
  • Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
  • Diagnosed or receiving treatment for Osteoporosis
  • Other physical disability affecting the hips, spine, or contralateral knee
  • Severe instability due to advanced loss of osteochondral structure
  • Prior arthroplasty of the affected knee
  • Compromised ACL, PCL or collateral ligament
  • Severe fixed valgus or varus deformity of \>15º
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Forest Ridge Medical Pavilion

New Castle, Indiana, 47362, United States

Location

Ochsner Sports Medicine Institute

New Orleans, Louisiana, 70121, United States

Location

Mansfield Orthopaedics

Morrisville, Vermont, 05661, United States

Location

MeSH Terms

Conditions

OsteoarthritisJoint Diseases

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • L Rolston, MD

    Forest Ridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 28, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2016

Study Completion

November 18, 2022

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)