Persona TKA With iASSIST Knee System and iASSIST Knee System

NCT03227692 | Completed Results FDA Device

• 1 other identifier: K.CR.I.AP.16.39
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain

  Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.

  Postoperative 6 months

• Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain

  Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.

  Postoperative 6 months

• Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain

  Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.

  Postoperative 6 months

• Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain

  Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.

  Postoperative 6 months

Secondary Outcomes (8)

• Surgery Time

  Intraoperative, an average of 2 hours

• Number of Instrument Trays Used

  Intraoperative

• KSS - Objective Score at 6 Month Postoperatively

  6 month postoperative

• KSS-Patient Satisfaction at 6 Month Postoperatively

  6 month postoperative

• KSS-function Score at 6 Month Postoperatively

  6 month postoperative

Study Arms (2)

Persona with iASSIST Knee

EXPERIMENTAL

Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.

Device: Persona Knee System; Procedure: Total Knee Arthroplasty; Device: iAssist Knee

Persona without iASSIST Knee

ACTIVE COMPARATOR

Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.

Device: Persona Knee System; Procedure: Total Knee Arthroplasty

Interventions

Persona Knee System DEVICE

Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.

Also known as: Persona Knee

Persona with iASSIST Knee; Persona without iASSIST Knee

Total Knee Arthroplasty PROCEDURE

Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.

Also known as: TKA

Persona with iASSIST Knee; Persona without iASSIST Knee

iAssist Knee DEVICE

Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.

Persona with iASSIST Knee

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a patient must meet all of the following criteria.
• Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
• Male or female
• At least 20 years of age
• Patients willing to return for follow-up evaluations.
• Study Specific Requirements for Principal Investigator/Site
• Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities.
• Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.

You may not qualify if:

• Absolute contraindications include:
• Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
• Too severe OA deformation (FTA: \> 190 degrees/\< 175 degrees)
• Active infection (or within 6 weeks after infection)
• Sepsis
• Osteomyelitis
• Any type of implant is inserted in the affected side of lower extremity
• Hip and/or foot disease on the affected side
• Additional contraindications include:
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions
• Diagnosed osteoporosis or osteomalacia
• Metabolic disorders which may impair bone formation
• Distant foci of infections which may spread to the implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Vascular insufficiency, muscular atrophy or neuromuscular disease.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Sumitomo Hopital

Osaka, Osaka, 530-0005, Japan

Location

Japanese Red Cross Medical Center

Shibuya City, Tokyo, 150-8935, Japan

Location

Yamaguchi Prefectural Grand Medical Center

Hōfu, Yamaguchi, 747-8511, Japan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Senior Manager of Clinical Affairs
• Organization: Zimmer Biomet G.K.

takahito.nakai@zimmerbiomet.com

+81-3-6402-6610

Study Officials

• Toshihiro Ohdera, M.D.

  Fukuoka Orthopaedic Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: August 18, 2017
• Primary Completion: November 14, 2019
• Study Completion: December 2, 2019
• Last Updated: July 2, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-01

Locations

JP (3)