Bicompartmental Osteoarthritis Clinical Trial
Official title:
A Prospective, Multicenter Study of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System
| NCT number | NCT01564641 |
| Other study ID # | 11-001 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2012 |
| Est. completion date | November 18, 2022 |
| Verified date | October 2023 |
| Source | Restor3D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To evaluate the ConforMIS iDuo G2 implant
| Status | Terminated |
| Enrollment | 150 |
| Est. completion date | November 18, 2022 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mansfield Orthopaedics | Morrisville | Vermont |
| United States | Forest Ridge Medical Pavilion | New Castle | Indiana |
| United States | Ochsner Sports Medicine Institute | New Orleans | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Restor3D |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain and function | By using questionnaires, we will look at pain and function scores at this time point | 3 months | |
| Secondary | Pain and function at follow up time points | By using questionnaires, we will look at pain and function scores at these time points | 1, 2, 5 and 10 years post implant | |
| Secondary | Revision rates | Capture revision rates | Patient will be observed for 10 years post implant | |
| Secondary | Incidence of major procedure related and device related complications | To capture any procedure or device related complications | Patient will be observed for 10 years post implant | |
| Secondary | Post operative limb alignment | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups | ||
| Secondary | Radiographic implant position | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups | ||
| Secondary | Radiographic loosening, radiolucencies | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups | ||
| Secondary | Length of procedure | Timing from skin to cement | Day of surgery | |
| Secondary | Length of hospital stay | measure length of stay from admission to discharge | Patient will be followed from admission to discharge with an average of about 5 days | |
| Secondary | Blood loss during surgery | Day of surgery | ||
| Secondary | Intraoperative blood replacement volume | Day of surgery |