Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

ConditionsKnee Osteoarthritis Knee Arthritis Knee Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorSoutheast Orthopedic Specialists

About this trial

The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:

* Will the patient reported outcomes differ between the two groups? * Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance).

Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor.

Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol.

Individuals who are male or non-pregnant female age 18-80 years at time of device implantation.

Disqualifiers

Patient has a Body Mass Index (BMI) > 40.

Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator.

Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency.

Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's).

Trial design

Design model

Single group

Treatments tested in this trial

Stryker Triathlon with MAKO Robotic-Arm
Device
Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm
DePuy Attune with VELYS Robotic-Assistance
Device
Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: MAKO groupExperimental treatment 1 intervention

Group B: VELYS groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

KSS

Knee Society Score

Time frame

baseline

KSS

Knee Society Score

Time frame

6 week

KSS

Knee Society Score

Time frame

12 week

KSS

Knee Society Score

Time frame

1 year

Secondary outcomes

Operative step time

Timing for use of robot during surgery

Time frame

Intraoperative

Other outcomes

Bone resected

Amount of bone resected

Time frame

Intraoperative

Costs for surgery

Factors associated with insurance costs for surgery

Time frame

Immediate post operative

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southeast Orthopedic Specialists

Lead sponsor

DePuy Orthopaedics

Collaborator

Stryker Orthopaedics

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: