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

Sponsor
ConforMIS, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01820650
Collaborator
(none)
359
Enrollment
9
Locations
156.9
Anticipated Duration (Months)
39.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: iTotal G2 CR Knee Replacement System

Detailed Description

If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.

Study Design

Study Type:
Observational
Actual Enrollment :
359 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Actual Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Mar 1, 2017
Anticipated Study Completion Date :
Mar 1, 2026

Outcome Measures

Primary Outcome Measures

  1. 2011 Knee Society Score [1 Year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

  • Severe fixed valgus or varus deformity of >15º

  • Extensor lag > 15 º

  • Fixed flexion contracture ≥ 15 º

  • Unwilling or unable to comply with study requirements

  • Participation in another clinical study which would confound results

  • Allergy to any of the implant materials

Contacts and Locations

Locations

Site City State Country Postal Code
1 JFK Medical Center Atlantis Florida United States 33462
2 EMMC - Orthopaedic Surgery of Maine Bangor Maine United States 04401
3 Great Lakes Bone and Joint Battle Creek Michigan United States 49015
4 Orthopaedic Instatute of Henderson Henderson Nevada United States 89052
5 Desert Orthopedic Center Las Vegas Nevada United States 89121
6 Tennessee Orthopaedic Alliance Nashville Tennessee United States 37203
7 Advanced Orthopedics and Sports Medicine Cypress Texas United States 77429
8 Joint Replacement Associates Houston Texas United States 77030
9 Mansfield Orthopaedics Morrisville Vermont United States 05661

Sponsors and Collaborators

  • ConforMIS, Inc.

Investigators

  • Study Director: Marc Quartulli, ConforMIS, Inc.
  • Principal Investigator: Terry Clyburn, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ConforMIS, Inc.
ClinicalTrials.gov Identifier:
NCT01820650
Other Study ID Numbers:
  • 12-001
First Posted:
Mar 29, 2013
Last Update Posted:
Nov 18, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by ConforMIS, Inc.
osteoarthritis
knee replacement
patient-specific
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 18, 2020