Study of the ConforMIS iDuo(R) G2

October 23, 2023 updated by: Restor3D

A Prospective, Multicenter Study of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System

To evaluate the ConforMIS iDuo G2 implant

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, multicenter study. The investigators will be evaluating the ConforMIS iDuo G2 implant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • New Castle, Indiana, United States, 47362
        • Forest Ridge Medical Pavilion
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Sports Medicine Institute
    • Vermont
      • Morrisville, Vermont, United States, 05661
        • Mansfield Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Clinical condition included in the approved Indications For Use for the iDuo® G2
  2. 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.
  3. Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
  4. > 18 years of age

Exclusion Criteria:

  1. BMI > 40
  2. 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
  3. Poorly controlled diabetes
  4. Neuromuscular conditions which prevent patient from participating in study activities
  5. Active local or systemic infection
  6. Immunocompromised
  7. Fibromyalgia or other general body pain related condition
  8. Rheumatoid arthritis or other forms of inflammatory joint disease
  9. 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
  10. Diagnosed or receiving treatment for Osteoporosis
  11. Other physical disability affecting the hips, spine, or contralateral knee
  12. Severe instability due to advanced loss of osteochondral structure
  13. Prior arthroplasty of the affected knee
  14. Compromised ACL, PCL or collateral ligament
  15. Severe fixed valgus or varus deformity of >15º
  16. Extensor lag > 15 º
  17. Fixed flexion contracture ≥ 10 º
  18. Prior history of failed implant surgery of the joint to be treated, including high tibial osteotomy (HTO)
  19. Unwilling or unable to comply with study requirements
  20. Participation in another clinical study which would confound results
  21. If during intra-op, it is noted that the patient has tri-compartmental disease, then the patient is considered a screen fail

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
iDuo G2
iDuo G2 to be implanted in the patient.
Device: iDuo G2
single comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain and function
Time Frame: 3 months
By using questionnaires, we will look at pain and function scores at this time point
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain and function at follow up time points
Time Frame: 1, 2, 5 and 10 years post implant
By using questionnaires, we will look at pain and function scores at these time points
1, 2, 5 and 10 years post implant
Revision rates
Time Frame: Patient will be observed for 10 years post implant
Capture revision rates
Patient will be observed for 10 years post implant
Incidence of major procedure related and device related complications
Time Frame: Patient will be observed for 10 years post implant
To capture any procedure or device related complications
Patient will be observed for 10 years post implant
Post operative limb alignment
Time Frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Radiographic implant position
Time Frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Radiographic loosening, radiolucencies
Time Frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Length of procedure
Time Frame: Day of surgery
Timing from skin to cement
Day of surgery
Length of hospital stay
Time Frame: Patient will be followed from admission to discharge with an average of about 5 days
measure length of stay from admission to discharge
Patient will be followed from admission to discharge with an average of about 5 days
Blood loss during surgery
Time Frame: Day of surgery
Day of surgery
Intraoperative blood replacement volume
Time Frame: Day of surgery
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Restor3D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: L Rolston, MD, Forest Ridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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