Bicompartmental Osteoarthritis
Conditions
Keywords
knee, osteoarthritis, bicompartmental, arthroplasty, joint diseases
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.
Interventions
DEVICEiDuo G2
single comparator
Sponsors
Restor3D
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain and function | 3 months | By using questionnaires, we will look at pain and function scores at this time point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and function at follow up time points | 1, 2, 5 and 10 years post implant | By using questionnaires, we will look at pain and function scores at these time points |
| Revision rates | Patient will be observed for 10 years post implant | Capture revision rates |
| Incidence of major procedure related and device related complications | Patient will be observed for 10 years post implant | To capture any procedure or device related complications |
| 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 | Day of surgery | Timing from skin to cement |
| Length of hospital stay | Patient will be followed from admission to discharge with an average of about 5 days | measure length of stay from admission to discharge |
| Blood loss during surgery | Day of surgery | — |
| Intraoperative blood replacement volume | Day of surgery | — |
Countries
United States
Outcome results
None listed