Study of the ConforMIS iDuo(R) G2

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Status: Terminated

Conditions: Bicompartmental Osteoarthritis

Treatments: Device: iDuo G2

Study type: Observational

Funder types: Industry

Identifiers

NCT01564641

11-001

Details and patient eligibility

About

To evaluate the ConforMIS iDuo G2 implant

Full description

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

iDuo G2

Description:

iDuo G2 to be implanted in the patient.

Treatment:

Device: iDuo G2