Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03106558
• Other study ID #: 2017WHoz
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 7, 2017
• Last updated: April 4, 2017
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: February 2017
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient requires primary total knee surgery

• Patient is willing and able to comply with postoperative follow-up requirements and self evaluations

• Patient is willing to sign an IRB approved informed consent

• Patient is at least 18 years of age

Exclusion Criteria:

• Patient has a BMI > 50

• Patient is skeletally immature

• Patient has an active infection or suspected infection in or about the joint

• Bone stock that is inadequate to support fixation of the prosthesis

• Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.

• Patients with mental or neurological conditions which may be incapable of following instructions.

• Blood supply limitations

• Collateral ligament insufficiency.

• Patients with prior HTOs or Unis.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Total Knee Arthroplasty using Manual Instrumentation

• Total Knee Arthroplasty using Robotic Arm

Locations

Country	Name	City	State
United States	Athens Orthopedic Clinic	Athens	Georgia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics	Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Component alignment	CT scan measurement	6 weeks post knee arthroplasty