Clinical trial NCT06284824: Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems
Official title: Prospective, Randomized, Single-center Study Comparing the Stryker MAKO™ Robotic-Arm Assisted Total Knee Arthroplasty and the DePuy VELYS™ Robotic-Assisted Solution for Total Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Knee Arthritis
Knee Disease
Keywords: robotic assistance
arthroplasty
TKA
Lead sponsor: Southeast Orthopedic Specialists
Sponsor class: NETWORK
Collaborators: name: DePuy Orthopaedics
name: Stryker Orthopaedics
First posted: 2024-02-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The purpose of this study is to compare two different total knee arthroplasty (TKA) robotic assisted (RA) devices. This study will compare patient reported outcome measures prior to and after surgery. These surveys will be used determine if there are differences in patient recovery after TKA depending on the robot used. Radiographs will also be taken and used to compare component positioning. Intraoperative data will be collected to compare OR efficiency of the two systems.

Eligibility criteria: Inclusion Criteria:

* 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.
* Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.

Exclusion Criteria:

* 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).
* Subject is a woman who is pregnant or lactating.
* Patient has a contralateral amputation.
* Patient's affected knee has a flexion contracture greater than 15 degrees.
* Patient has history of post operative arthrofibrosis.
* Patient's affected knee has a partial knee arthroplasty.
* Patient has undergone contralateral TKA within the last three months.
* Patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims.
* Patient who is bedridden per the discretion of the investigator.
* Patient has a medical condition with less than 2 years of life expectancy.

Primary outcomes:
measure: KSS
timeFrame: baseline
measure: KSS
timeFrame: 6 week
measure: KSS
timeFrame: 12 week
measure: KSS
timeFrame: 1 year
measure: KOOS JR
timeFrame: baseline
measure: KOOS JR
timeFrame: 6 week
measure: KOOS JR
timeFrame: 12 week
measure: KOOS JR
timeFrame: 1 year
measure: FJS-12 Knee
timeFrame: 6 week
measure: FJS-12 Knee
timeFrame: 12 week
measure: FJS-12 Knee
timeFrame: 1 year
Secondary outcomes:
measure: Operative step time
timeFrame: Intraoperative
Other outcomes:
measure: Bone resected
timeFrame: Intraoperative
measure: Costs for surgery
timeFrame: Immediate post operative
Locations:
Study officials:
affiliation: Southeast Orthopedic Specialists
name: John Redmond, MD
role: PRINCIPAL_INVESTIGATOR
References: