Status:
TERMINATED
iUni G2+ Prospective Study
Lead Sponsor:
Restor3D
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Brief Summary
This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement
Detailed Description
The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.
Eligibility Criteria
Inclusion
- Clinical condition included in the approved Indications For Use
- Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
- Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- \> 18 years of age
Exclusion
- Simultaneous bilateral procedure required
- BMI \> 35
- Treatment for cancer within the past 5 years, with the exception of skin cancer
- Poorly controlled diabetes
- Neuromuscular conditions which prevent patient from participating in study activities
- Active local or systemic infection
- Immunocompromised
- Fibromyalgia or other general body pain related condition
- Advanced tricompartmental osteoarthritis
- Symptomatic patellofemoral disease
- Rheumatoid arthritis or other forms of inflammatory joint disease (excluding Gout unless it is in the treated knee or limiting overall function)
- Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified. Osteoporosis is defined by more than -2.5 standard deviations from the T score as measured on a Dual Energy X-Ray Absortiometry Scan (DEXA) within 2 years of surgery.
- Advanced loss of osteochondral structure on the affected femoral condyle
- Compromised ACL, PCL or collateral ligament
- Severe (\>15º) fixed valgus or varus deformity
- Extension deficit \> 15 º
- Prior history of failed implant surgery of the joint to be treated
- Unwilling or unable to comply with study requirements
- Participation in another clinical study which would confound results
Key Trial Info
Start Date :
July 15 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 14 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01820676
Start Date
July 15 2013
End Date
October 14 2022
Last Update
October 25 2023
Active Locations (1)
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1
The London Clinic
London, United Kingdom