Osteo Arthritis KneeNCT03427047
Comparing Surgical and Economical Parameters of Total Knee Replacement.
A study testing MyKnee with single use Efficiency Instrument and Stryker Navigational with conventional metal instruments in people with Osteo Arthritis Knee and Total Knee Arthroplasty, run by Medacta USA at 1 site in United States.
Trial summary
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Total Knee Arthroplasty
- What is being tested?
- MyKnee with single use Efficiency Instrument and Stryker Navigational with conventional metal instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Who cannot join
- Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Sports Medicine Research & Education Foundation
Indianapolis, Indiana, 46280
About this study
Official title: A Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed Using Two Different Surgical Techniques: Medacta MyKnee® Surgical Technique Using Efficiency Single-use Instruments Versus Stryker Navigation Surgical Technique Performed With Conventional Metal Instruments.
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.
Read the detailed description
Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single use instruments versus Stryker Navigation surgical techniques performed with conventional instruments. MyKnee surgical technique patients will receive a CT scan of the surgical knee which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational surgical technique patients will not require a CT scan. Both groups of patients will undergo total knee arthroplasty.
- Conditions
- Osteo Arthritis Knee, Total Knee Arthroplasty
- Being tested
- MyKnee with single use Efficiency Instrument, Stryker Navigational with conventional metal instruments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyKnee with single use Efficiency InstrumentDevice
Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation
Stryker Navigational with conventional metal instrumentsDevice
Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.
| Study group | Role | What they receive |
|---|---|---|
| MyKnee with single use Efficiency Instrument | Active comparator | Patients randomized in this group will undergo Total Knee Arthroplasty utilizing patient matched cutting blocks and single use instruments. Customization will be by a CT scan of patients knee. Receives: Device: MyKnee with single use Efficiency Instrument |
| Stryker Navigational with conventional metal instruments | Active comparator | Patients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm. Receives: Device: Stryker Navigational with conventional metal instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Time-saving Associated With the Two Procedures.
Measure clean up time at end of surgery in minutes
Measured: Day of surgery
Patient OR Time From Both Study Arms
Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes
Measured: Day of surgery
Secondary outcomes (8)
Estimated Blood Loss From Both Study Arms
Volume of estimated blood loss in cc's
Measured: Day of surgery
Baseline of Hemoglobin Both Study Arms
Measure in grams per deciliter
Measured: Baseline, 1 day post-op or at discharge from hospital
Volume of Transfusions Both Study Arms
Measure amount of blood patient receives in ML
Measured: Day of surgery
Instrument Trays Sent to Sterilization Both Study Arms
Record number of trays sent to be sterilized
Measured: Day of surgery
Amount of Waste From Surgery Both Study Arms
Combined weight of recyclable and non-recyclable waste in grams
Measured: Day of surgery
Baseline of Mechanical Axis Both Study Arms
Determine radiographic analysis by measuring knee mechanical axis in degrees
Measured: Baseline, post-operative 6 weeks
Change From Baseline of Tibial Slope Both Study Arms
Determine radiographic analysis by measuring tibial angles in degrees
Measured: Baseline, post-operative 6 weeks
Related Complications
Assess adverse events and serious adverse events related to both procedures
Measured: Baseline, day of surgery, post-op 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Aug 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hur, MD, Principal investigator, Forte Sports Medicine and Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427047
- Sponsor's protocol ID
- MyKnee 20170612
- Status last verified
- May 2023
- First submitted
- 2 Feb 2018
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed Using Two Different Surgical Techniques: Medacta MyKnee® Surgical Technique Using Efficiency Single-use Instruments Versus Stryker Navigation Surgical Technique Performed With Conventional Metal Instruments.
- ClinicalTrials.gov ID
- NCT03427047
- Acronym / sponsor ID
- MyKnee 20170612
- Conditions
- Osteo Arthritis Knee, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.
Detailed description
Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single use instruments versus Stryker Navigation surgical techniques performed with conventional instruments. MyKnee surgical technique patients will receive a CT scan of the surgical knee which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational surgical technique patients will not require a CT scan. Both groups of patients will undergo total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyKnee with single use Efficiency Instrument | Active comparator | Device: MyKnee with single use Efficiency InstrumentPatients randomized in this group will undergo Total Knee Arthroplasty utilizing patient matched cutting blocks and single use instruments. Customization will be by a CT scan of patients knee. |
| Stryker Navigational with conventional metal instruments | Active comparator | Device: Stryker Navigational with conventional metal instrumentsPatients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Key exclusion criteria (1 listed)
- Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyKnee with single use Efficiency InstrumentTotal Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation | Device | MyKnee with single use Efficiency Instrument |
| Stryker Navigational with conventional metal instrumentsTotal Knee Arthroplasty without customization of cutting blocks using conventional metal instruments. | Device | Stryker Navigational with conventional metal instruments |
Primary outcome
Compare Time-saving Associated With the Two Procedures.
Time frame: Day of surgery
Measure clean up time at end of surgery in minutes
Patient OR Time From Both Study Arms
Time frame: Day of surgery
Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes
8 secondary outcomes
Estimated Blood Loss From Both Study Arms
Time frame: Day of surgery
Baseline of Hemoglobin Both Study Arms
Time frame: Baseline, 1 day post-op or at discharge from hospital
Volume of Transfusions Both Study Arms
Time frame: Day of surgery
Instrument Trays Sent to Sterilization Both Study Arms
Time frame: Day of surgery
Amount of Waste From Surgery Both Study Arms
Time frame: Day of surgery
Baseline of Mechanical Axis Both Study Arms
Time frame: Baseline, post-operative 6 weeks
Change From Baseline of Tibial Slope Both Study Arms
Time frame: Baseline, post-operative 6 weeks
Related Complications
Time frame: Baseline, day of surgery, post-op 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hur, MD principal investigator
Forte Sports Medicine and Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyKnee with single use Efficiency Instrument and Stryker Navigational with conventional metal instruments in people with Osteo Arthritis Knee and Total Knee Arthroplasty, run by Medacta USA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Time-saving Associated With the Two Procedures. (time frame: Day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.