Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

restor3d

Status: Terminated

Conditions: Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01861028

12-002

Details and patient eligibility

About

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

Full description

The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.

All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

44 participants in 2 patient groups

Phase I

Description:

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

Description:

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.