Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique
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.
1 other identifier
interventional
32
1 country
5
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Start
First participant enrolled
October 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedResults Posted
Study results publicly available
August 8, 2023
CompletedAugust 8, 2023
June 1, 2023
4.5 years
April 20, 2017
June 30, 2023
August 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
OR Total Time
Total time patient is in operating room
Day of Surgery
Opening Instruments
Time to open surgical instruments
Day of Surgery
Back Table Setup Time
Time to set up back surgical table
Day of Surgery
Tourniquet Time
Time tourniquet is on patient during surgery
Day of Surgery
Incision to Skin Closure
Time from incision to skin closure during surgery
Day of Surgery
Bone Prep Time
Time to prepare bone for implant during surgery
Day of Surgery
Patella Resection Time
Time to resection patella during surgery
Day of Surgery
Clean-up Time
Time to clean up following surgery
Day of Surgery
Secondary Outcomes (6)
Hemoglobin Range
24 hours or at discharge if patient does not stay overnight
Surgical Waste Weight
Day of Surgery
Mechanical Axis
Pre-Operative
Mechanical Axis
Post-Operative
Tibial Slope
Pre-Operative
- +1 more secondary outcomes
Study Arms (2)
Customized patient instruments
EXPERIMENTALExperimental 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 COMPARATORControl Group: Patients will undergo conventional surgical technique
Interventions
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 instrument will be used to make bone cuts and size the components in this control group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medacta USAlead
Study Sites (5)
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072, United States
Ortho Montana
Billings, Montana, 59101, United States
Orthopedic Associates Meadville
Meadville, Pennsylvania, 16335, United States
Texas Orthopedics
Austin, Texas, 78759, United States
Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
West Jordan, Utah, 84088, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rena Mandino, Director of Clinical Research
- Organization
- Medacta USA
Study Officials
- STUDY DIRECTOR
Mukesh Ahuja, MBBS, MS
Medacta USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2017
First Posted
May 11, 2017
Study Start
October 11, 2017
Primary Completion
March 30, 2022
Study Completion
March 30, 2022
Last Updated
August 8, 2023
Results First Posted
August 8, 2023
Record last verified: 2023-06