A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

Osteoarthritis Clinical Trial

Official title:

A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02494544
• Other study ID #: 12-005
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: November 16, 2022

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.

The patient will conduct functional testing and answer questionnaires.

The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.

Description:

To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 187
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

• 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:

• Subject will require a simultaneous bilateral procedure

• Other lower extremity surgery within 1 year

• Severe (> 15º) fixed valgus or varus deformity

• Severe (> 15º) extension deficit

• Severe instability due to advanced loss of osteochondral structure

• Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified

• Insufficient bone stock on the femoral or tibial surfaces

• Contralateral knee replacement surgery within the past 6 months

• 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 (defined as HbA1c >7 or surgeon discretion)

• Immunocompromised

• Other physical disability affecting the hips, spine, or contralateral knee that limits function

• Disabling chronic pain with narcotic dependence

• Compromised PCL or collateral ligament

• Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA)

• Prior history of failed high tibial osteotomy (HTO)

• Participation in another clinical study which would confound results

• Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker
• ConforMIS iTotal Knee Replacement
A knee replacement performed with patient specific implant and surgical jigs.

Locations

Country	Name	City	State
United States	OrthoNY	Albany	New York
United States	Tufts University	Boston	Massachusetts
United States	The Lindner Center for Research and Education	Cincinnati	Ohio
United States	University of Missouri	Columbia	Missouri
United States	University of California in San Diego	La Jolla	California
United States	Yale School of Medicine	New Haven	Connecticut
United States	Denver-Vail Orthopedics	Parker	Colorado
United States	Sharp Healthcare	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Testing	Comparing the functional testing differences between iTotal and off the shelf	1 year
Secondary	Patient reported outcome using questionnaires such as the KOOS and VAS	Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes.	1 year
Secondary	Incidents of major procedure-related and device related complications (including revision rates)	To compare revision rates between groups	1 year
Secondary	Post-operative limb alignment based using x-ray views	To compare post-operative limb alignment between two groups	1 year