OsteoarthritisNCT03148379
Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique
A study testing Customized patient instruments and Traditional Metal Instruments in people with Osteoarthritis, run by Medacta USA at 5 sites in United States.
Trial summary
To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Customized patient instruments and Traditional Metal Instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Oct 2017to 30 Mar 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years
- BMI ≤35
- Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA)
- Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Who cannot join
- Pregnant women or those seeking to become pregnant. Pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential
- Is participating in another clinical study
- Has inflammatory arthritis
- Has knee avascular necrosis
- Has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis
- Has retained hardware in the knee that requires removal or interferes with Total Knee Arthroplasty (TKA) procedure
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Texas Orthopedics
Austin, Texas, 78759
Ortho Montana
Billings, Montana, 59101
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
Orthopedic Associates Meadville
Meadville, Pennsylvania, 16335
Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
West Jordan, Utah, 84088
About this study
Official title: A Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique.
To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique
- Conditions
- Osteoarthritis
- Being tested
- Customized patient instruments, Traditional Metal Instruments
- Keywords
- Total Knee Replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized patient instrumentsDevice
Also called Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®)
Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
Traditional Metal InstrumentsDevice
Also called Traditional Metal Instruments with Conventional Surgical Technique
Traditional metal instrument will be used to make bone cuts and size the components in this control group.
| Study group | Role | What they receive |
|---|---|---|
| Customized patient instruments | Experimental | Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks) Receives: Device: Customized patient instruments |
| Traditional metal instruments | Active comparator | Control Group: Patients will undergo conventional surgical technique Receives: Device: Traditional Metal Instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
OR Total Time
Total time patient is in operating room
Measured: Day of Surgery
Opening Instruments
Time to open surgical instruments
Measured: Day of Surgery
Back Table Setup Time
Time to set up back surgical table
Measured: Day of Surgery
Tourniquet Time
Time tourniquet is on patient during surgery
Measured: Day of Surgery
Incision to Skin Closure
Time from incision to skin closure during surgery
Measured: Day of Surgery
Bone Prep Time
Time to prepare bone for implant during surgery
Measured: Day of Surgery
Patella Resection Time
Time to resection patella during surgery
Measured: Day of Surgery
Clean-up Time
Time to clean up following surgery
Measured: Day of Surgery
Secondary outcomes (6)
Hemoglobin Range
Post op 1 day hemoglobin range
Measured: 24 hours or at discharge if patient does not stay overnight
Surgical Waste Weight
Weigh surgical waste at the end of each surgery
Measured: Day of Surgery
Mechanical Axis
Radiographic analysis of mechanical axis alignment
Measured: Pre-Operative
Mechanical Axis
Radiographic analysis of mechanical axis alignment
Measured: Post-Operative
Tibial Slope
Radiographic analysis of Tibial Posterior Slope
Measured: Pre-Operative
Tibial Slope
Radiographic analysis of Tibial Posterior Slope
Measured: Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start11 Oct 2017
- Primary completion30 Mar 2022
- Study completion30 Mar 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 OsteoarthritisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mukesh Ahuja, MBBS, MS, Study director, Medacta USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148379
- Sponsor's protocol ID
- 20161119
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2017
- Last updated
- 8 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique.
- ClinicalTrials.gov ID
- NCT03148379
- Acronym / sponsor ID
- 20161119
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 8 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized patient instruments | Experimental | Device: Customized patient instrumentsExperimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks) |
| Traditional metal instruments | Active comparator | Device: Traditional Metal InstrumentsControl Group: Patients will undergo conventional surgical technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75 years
- BMI ≤35
- Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA)
- Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Key exclusion criteria (6 listed)
- Pregnant women or those seeking to become pregnant. Pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential
- Is participating in another clinical study
- Has inflammatory arthritis
- Has knee avascular necrosis
- Has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis
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 |
|---|---|---|
| Customized patient instrumentsAlso: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®)Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size. | Device | Customized patient instruments |
| Traditional Metal InstrumentsAlso: Traditional Metal Instruments with Conventional Surgical TechniqueTraditional metal instrument will be used to make bone cuts and size the components in this control group. | Device | Traditional metal instruments |
Primary outcome
OR Total Time
Time frame: Day of Surgery
Total time patient is in operating room
Opening Instruments
Time frame: Day of Surgery
Time to open surgical instruments
Back Table Setup Time
Time frame: Day of Surgery
Time to set up back surgical table
Tourniquet Time
Time frame: Day of Surgery
Time tourniquet is on patient during surgery
Incision to Skin Closure
Time frame: Day of Surgery
Time from incision to skin closure during surgery
Bone Prep Time
Time frame: Day of Surgery
Time to prepare bone for implant during surgery
Patella Resection Time
Time frame: Day of Surgery
Time to resection patella during surgery
Clean-up Time
Time frame: Day of Surgery
Time to clean up following surgery
6 secondary outcomes
Hemoglobin Range
Time frame: 24 hours or at discharge if patient does not stay overnight
Surgical Waste Weight
Time frame: Day of Surgery
Mechanical Axis
Time frame: Pre-Operative
Mechanical Axis
Time frame: Post-Operative
Tibial Slope
Time frame: Pre-Operative
Tibial Slope
Time frame: Post-Operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mukesh Ahuja, MBBS, MS study director
Medacta USA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized patient instruments and Traditional Metal Instruments in people with Osteoarthritis, run by Medacta USA at 5 sites 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 4 inclusion and 6 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 8 Aug 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?
OR Total Time (time frame: Day of Surgery). The study lists 8 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 8 Aug 2023.