Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

NCT01861028 | Terminated Results

• 1 other identifier: 12-002
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants

Conditions

Osteoarthritis

Keywords

total knee replacement; total knee arthroplasty; patient-specific

Outcome Measures

Primary Outcomes (2)

• Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater

  Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.

  Intraoperatively, up to 120 minutes

• Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater

  Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia.

  Intraoperatively, up to 120 minutes

Study Arms (2)

Phase I

A series of 50 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements

Phase II

The Phase I (50 consecutive primary iTotal patients) will also have implant fit data assessed for the femur. After final implantation is complete measurement will be assessed and recorded. A series of 25 primary knees that are scheduled for Standard TKR implants will then undergo the same measurements of the femur.

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 receiving either a standard total knee implant or an iTotal patient-specific total knee implant

You may qualify if:

• Patients who are scheduled for a standard total knee replacement
• Patient who are scheduled for patient-specific total knee replacement (iTotal)
• Patient age \> 18 years

You may not qualify if:

• Patients who do not receive a total knee replacement
• Unwilling or unable to comply with study requirements

Sponsors & Collaborators

• Restor3D: lead

Study Sites (1)

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Director of Clinical and Technical Research
• Organization: Conformis

sumesh.zingde@conformis.com

781-345-9103

Study Officials

• Gregory Martin, MD

  JFK Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 23, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 25, 2023
• Results First Posted: December 28, 2020

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)