Comparing Surgical and Economical Parameters of Total Knee Replacement.

NCT03427047 | Completed Results FDA Device

• 1 other identifier: MyKnee 20170612
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.

Conditions

Osteo Arthritis Knee; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Compare Time-saving Associated With the Two Procedures.

  Measure clean up time at end of surgery in minutes

  Day of surgery

• Patient OR Time From Both Study Arms

  Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes

  Day of surgery

Secondary Outcomes (8)

• Estimated Blood Loss From Both Study Arms

  Day of surgery

• Baseline of Hemoglobin Both Study Arms

  Baseline, 1 day post-op or at discharge from hospital

• Volume of Transfusions Both Study Arms

  Day of surgery

• Instrument Trays Sent to Sterilization Both Study Arms

  Day of surgery

• Amount of Waste From Surgery Both Study Arms

  Day of surgery

Study Arms (2)

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.

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.

Device: Stryker Navigational with conventional metal instruments

Interventions

MyKnee with single use Efficiency Instrument DEVICE

Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation

MyKnee with single use Efficiency Instrument

Stryker Navigational with conventional metal instruments DEVICE

Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.

Stryker Navigational with conventional metal instruments

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (1)

Methodist Sports Medicine Research & Education Foundation

Indianapolis, Indiana, 46280, United States

Location

Results Point of Contact

• Title: Rena Mandino, Director, Clinical Research
• Organization: Medacta USA

rmandino@medacta.us.com

352-359-3581

Study Officials

• John Hur, MD

  Forte Sports Medicine and Orthopedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 9, 2018
• Study Start: August 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-05

Locations

US (1)