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iUni G2+ Prospective Study

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ClinicalTrials.gov Identifier: NCT01820676
Recruitment Status : Active, not recruiting
First Posted : March 29, 2013
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Brief Summary:
This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement

Condition or disease Intervention/treatment
Knee Osteoarthritis Device: iUni G2+

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.

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2+ Unicompartmental Knee Resurfacing Device
Actual Study Start Date : July 15, 2013
Actual Primary Completion Date : July 1, 2017
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
iUni G2+
iUni G2+ in all patients
Device: iUni G2+
The iUni G2+ Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation (Fitz).




Primary Outcome Measures :
  1. 2011 Knee Society Score [ Time Frame: 1 Year ]
  2. KOOS Score [ Time Frame: 1 Year ]
  3. Oxford Knee Score [ Time Frame: 1 Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with knee osteoarthritis
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820676


Locations
United Kingdom
The London Clinic
London, United Kingdom
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
Principal Investigator: Dinesh Nathwani, MD The London Clinic

Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01820676     History of Changes
Other Study ID Numbers: 12-004
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases