This trial is active, not recruiting.

Condition bicompartmental osteoarthritis
Treatment iduo g2
Phase phase 4
Sponsor ConforMIS, Inc.
Start date May 2012
End date August 2016
Trial size 150 participants
Trial identifier NCT01564641, 11-001


To evaluate the ConforMIS iDuo G2 implant

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
iDuo G2 to be implanted in the patient.
iduo g2 iDuo G2
single comparator

Primary Outcomes

Pain and function
time frame: 3 months

Secondary Outcomes

Pain and function at follow up time points
time frame: 1, 2, 5 and 10 years post implant
Revision rates
time frame: 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
Post operative limb alignment
time frame: 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
Radiographic loosening, radiolucencies
time frame: 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
Length of hospital stay
time frame: Patient will be followed from admission to discharge with an average of about 5 days
Blood loss during surgery
time frame: Day of surgery
Intraoperative blood replacement volume
time frame: Day of surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective, Multicenter Study of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System
Principal investigator L Rolston, MD
Description This is a prospective, multicenter study. The investigators will be evaluating the ConforMIS iDuo G2 implant.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by ConforMIS, Inc..