NCT03106558

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 10, 2017

Status Verified

February 1, 2017

Enrollment Period

3 years

First QC Date

February 7, 2017

Last Update Submit

April 4, 2017

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Component alignment

    CT scan measurement

    6 weeks post knee arthroplasty

Study Arms (2)

Manual instrument total knee replacement

ACTIVE COMPARATOR
Device: Total Knee Arthroplasty using Manual Instrumentation

Robitic arm total knee replacement

ACTIVE COMPARATOR
Device: Total Knee Arthroplasty using Robotic Arm

Interventions

Total Knee Arthroplasty using Manual InstrumentationDEVICE
Manual instrument total knee replacement
Total Knee Arthroplasty using Robotic ArmDEVICE
Robitic arm total knee replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Athens Orthopedic Clinic

Athens, Georgia, 30606, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

April 10, 2017

Study Start

June 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

April 10, 2017

Record last verified: 2017-02

Locations

US(4)