Study of the ConforMIS iDuo(R) G2

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

To evaluate the ConforMIS iDuo G2 implant

Study Overview

• Status: Terminated
• Conditions: Bicompartmental Osteoarthritis
• Intervention / Treatment: Device: iDuo G2

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iDuo G2; iDuo G2 to be implanted in the patient.	Device: iDuo G2; single comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and function	By using questionnaires, we will look at pain and function scores at this time point	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and function at follow up time points	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	Capture revision rates	Patient will be observed for 10 years post implant
Incidence of major procedure related and device related complications	To capture any procedure or 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
Radiographic loosening, radiolucencies		X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
Length of procedure	Timing from skin to cement	Day of surgery
Length of hospital stay	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		Day of surgery
Intraoperative blood replacement volume		Day of surgery

Collaborators and Investigators

• Sponsor: Restor3D
• Investigators: Principal Investigator: L Rolston, MD, Forest Ridge

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): November 18, 2022

Study Registration Dates

• First Submitted: March 12, 2012
• First Submitted That Met QC Criteria: March 26, 2012
• First Posted (Estimated): March 28, 2012

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; arthroplasty; bicompartmental; joint diseases
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID 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