A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

NCT01820650 | Terminated FDA Device

• 1 other identifier: 12-001
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 9

Brief Summary

This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee replacement; patient-specific

Outcome Measures

Primary Outcomes (1)

• 2011 Knee Society Score

  1 Year

Interventions

iTotal G2 CR Knee Replacement System DEVICE

Total Knee replacement

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 with osteoarthritis of the knee

You may qualify if:

• Clinical condition included in the approved Indications For Use for the iTotal® CR
• Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
• 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 \> 40
• 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
• 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
• Rheumatoid arthritis or other forms of inflammatory joint disease
• 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
• Diagnosed with or receiving treatment for Osteoporosis
• Other physical disability affecting the hips, spine, or contralateral knee.
• Severe instability due to advanced loss of osteochondral structure
• Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
• Compromised PCL or collateral ligament

Sponsors & Collaborators

• Restor3D: lead

Study Sites (9)

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

EMMC - Orthopaedic Surgery of Maine

Bangor, Maine, 04401, United States

Location

Great Lakes Bone and Joint

Battle Creek, Michigan, 49015, United States

Location

Orthopaedic Instatute of Henderson

Henderson, Nevada, 89052, United States

Location

Desert Orthopedic Center

Las Vegas, Nevada, 89121, United States

Location

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37203, United States

Location

Advanced Orthopedics and Sports Medicine

Cypress, Texas, 77429, United States

Location

Joint Replacement Associates

Houston, Texas, 77030, United States

Location

Mansfield Orthopaedics

Morrisville, Vermont, 05661, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marc Quartulli

  Restor3D

  STUDY DIRECTOR

• Terry Clyburn, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: October 1, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)