Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Customized patient instruments; Device: Traditional Metal Instruments

• Registration Number: NCT03148379
• Lead Sponsor: Medacta USA

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-11
• Study Start: 2017-10-11
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2023-06
• Results First Submitted: 2023-06-30
• Results First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-04
• Results First Posted: 2023-08-08
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Customized patient instruments	Customized patient instruments	Experimental 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	Traditional Metal Instruments	Control Group: Patients will undergo conventional surgical technique

Primary Outcome Measures

Name	Time	Method
Patella Resection Time	Day of Surgery	Time to resection patella during surgery
Tourniquet Time	Day of Surgery	Time tourniquet is on patient during surgery
OR Total Time	Day of Surgery	Total time patient is in operating room
Opening Instruments	Day of Surgery	Time to open surgical instruments
Back Table Setup Time	Day of Surgery	Time to set up back surgical table
Incision to Skin Closure	Day of Surgery	Time from incision to skin closure during surgery
Bone Prep Time	Day of Surgery	Time to prepare bone for implant during surgery
Clean-up Time	Day of Surgery	Time to clean up following surgery

Secondary Outcome Measures

Name	Time	Method
Mechanical Axis	Post-Operative	Radiographic analysis of mechanical axis alignment
Tibial Slope	Post-Operative	Radiographic analysis of Tibial Posterior Slope
Hemoglobin Range	24 hours or at discharge if patient does not stay overnight	Post op 1 day hemoglobin range
Surgical Waste Weight	Day of Surgery	Weigh surgical waste at the end of each surgery

Trial Locations

Locations (5)

Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence; 🇺🇸 West Jordan, Utah, United States

Orthopedic Associates Meadville; 🇺🇸 Meadville, Pennsylvania, United States

Texas Orthopedics; 🇺🇸 Austin, Texas, United States

Tandem Clinical Research, LLC; 🇺🇸 Marrero, Louisiana, United States

Ortho Montana; 🇺🇸 Billings, Montana, United States