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Study of the ConforMIS iDuo(R) G2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564641
Recruitment Status : Active, not recruiting
First Posted : March 28, 2012
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Brief Summary:
To evaluate the ConforMIS iDuo G2 implant

Condition or disease Intervention/treatment
Bicompartmental Osteoarthritis Device: iDuo G2

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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Study of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System
Actual Study Start Date : May 2012
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pain and function [ Time Frame: 3 months ]
    By using questionnaires, we will look at pain and function scores at this time point


Secondary Outcome Measures :
  1. 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

  2. Revision rates [ Time Frame: Patient will be observed for 10 years post implant ]
    Capture revision rates

  3. 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

  4. Post operative limb alignment [ Time Frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups ]
  5. Radiographic implant position [ Time Frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups ]
  6. Radiographic loosening, radiolucencies [ Time Frame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups ]
  7. Length of procedure [ Time Frame: Day of surgery ]
    Timing from skin to cement

  8. 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

  9. Blood loss during surgery [ Time Frame: Day of surgery ]
  10. Intraoperative blood replacement volume [ Time Frame: Day of surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting this specific form of osteoarthritis at participating sites with IRB approval.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564641


Locations
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United States, Indiana
Forest Ridge Medical Pavilion
New Castle, Indiana, United States, 47362
United States, Louisiana
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States, 70121
United States, Vermont
Mansfield Orthopaedics
Morrisville, Vermont, United States, 05661
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
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Principal Investigator: L Rolston, MD Forest Ridge
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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01564641    
Other Study ID Numbers: 11-001
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ConforMIS, Inc.:
knee
osteoarthritis
bicompartmental
arthroplasty
joint diseases
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases