Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

NCT01117571 | Terminated FDA Device

• 1 other identifier: 09-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 8

Brief Summary

Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.

Conditions

Osteoarthritis

Keywords

knee; osteoarthritis; unicompartmental; arthroplasty; knee resurfacing; Conformis; patient specific

Outcome Measures

Primary Outcomes (2)

• Knee Society Score

  to assess knee pain and function

  2 years

• WOMAC Osteoarthritis Index

  to assess knee pain and function

  2 years

Secondary Outcomes (5)

• Knee Society Score and WOMAC at years 5 and 10 post-implantation

  10 years

• Annual revision rates at years 1 through 10 post-implantation

  10 years

• Incidence of major procedure-related and device-related complications

  10 years

• Length of tourniquet time in minutes

  6 weeks

• Length of hospital stay in hours

  6 weeks

Study Arms (1)

open label

iUni® Unicompartmental Knee Resurfacing Device

Device: iUni® Unicompartmental Knee Resurfacing Device

Interventions

iUni® Unicompartmental Knee Resurfacing Device DEVICE

The iUni® Unicompartmental Resurfacing Device 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

open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 who have uni-compartmental osteoarthritis to be treated with a unilateral knee resurfacing procedure

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Advanced loss of osteochondral structure on the affected femoral condyle
• Compromised ACL, PCL or collateral ligament
• Severe (\>15º) fixed valgus or varus deformity

Sponsors & Collaborators

• Restor3D: lead

Study Sites (8)

Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility

Little Rock, Arkansas, 72205, United States

Location

S.T.A.R. Orthopaedics

La Quinta, California, 92253, United States

Location

Center for the Knee and Shoulder

Monterey, California, 93940, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Heekin Clinic

Jacksonville, Florida, 32204, United States

Location

Great Lakes Bone and Joint

Battle Creek, Michigan, 49015, United States

Location

Orthopedic Associates of Pittsburgh

Monroeville, Pennsylvania, 15146, United States

Location

Advanced Orthopedics and Sports Medicine

Cypress, Texas, 77429, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• C. Lowry Barnes, M.D

  Hip Knee Arkansas Foundation

  PRINCIPAL INVESTIGATOR

• Marc Quartulli

  Restor3D

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: April 1, 2010
• Primary Completion: October 30, 2014
• Study Completion: January 10, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)