Clinical trial NCT01564641: Study of the ConforMIS iDuo(R) G2
Official title: A Prospective, Multicenter Study of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bicompartmental Osteoarthritis
Keywords: knee
osteoarthritis
bicompartmental
arthroplasty
joint diseases
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting this specific form of osteoarthritis at participating sites with IRB approval.

Brief summary: To evaluate the ConforMIS iDuo G2 implant

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

Eligibility 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

Primary outcomes:
measure: Pain and function
timeFrame: 3 months
Secondary outcomes:
measure: Pain and function at follow up time points
timeFrame: 1, 2, 5 and 10 years post implant
measure: Revision rates
timeFrame: Patient will be observed for 10 years post implant
measure: Incidence of major procedure related and device related complications
timeFrame: Patient will be observed for 10 years post implant
measure: Post operative limb alignment
timeFrame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
measure: Radiographic implant position
timeFrame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
measure: Radiographic loosening, radiolucencies
timeFrame: X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups
measure: Length of procedure
timeFrame: Day of surgery
measure: Length of hospital stay
timeFrame: Patient will be followed from admission to discharge with an average of about 5 days
measure: Blood loss during surgery
timeFrame: Day of surgery
measure: Intraoperative blood replacement volume
timeFrame: Day of surgery
Other outcomes:
Locations:
city: New Castle
country: United States
facility: Forest Ridge Medical Pavilion
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Sports Medicine Institute
state: Louisiana
city: Morrisville
country: United States
facility: Mansfield Orthopaedics
state: Vermont
Study officials:
affiliation: Forest Ridge
name: L Rolston, MD
role: PRINCIPAL_INVESTIGATOR
References: