Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
150 participants
OBSERVATIONAL
2012-05-31
2022-11-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
iUni G2+ Prospective Study
NCT01820676
Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant
NCT01117571
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
NCT01820650
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
NCT02494544
A Study to Evaluate the Conformis iTotal Identity Knee Replacement System
NCT04667559
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
iDuo G2
iDuo G2 to be implanted in the patient.
iDuo G2
single comparator
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
iDuo G2
single comparator
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Restor3D
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
L Rolston, MD
Role: PRINCIPAL_INVESTIGATOR
Forest Ridge
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Forest Ridge Medical Pavilion
New Castle, Indiana, United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States
Mansfield Orthopaedics
Morrisville, Vermont, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.