iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty Using the Persona Knee System Among Patients With BMI>=30: Radiographic, Clinical and Economic Outcomes

NCT ID: NCT02117973

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30

Brief Summary

The purpose of this prospective randomized study is to evaluate iAssist with respect to radiographic, clinical and economic outcomes in comparison to conventional instrumentation in primary total knee arthroplasty using the Persona knee system among patients with BMI>=30.

Conditions

Primary Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Technique using Persona prosthesis

The surgeon will realize the implantation of the Persona prosthesis according to the surgical technique. Potential variables such as methodology for determining tibial rotation, measuring of bone cuts, and any intra-operative adjustments will be captured on the operative case report form.

Group Type: ACTIVE_COMPARATOR

iAssist Technique using Persona system vs. the conventional technique using Persona system

Intervention Type: PROCEDURE

iAssist Technique using Persona prosthesis

iAssist is an electronic displacement sensor based instrumentation system that provides intra-operative verification at each surgical step (bone cuts alignment and resection level); in order to help reduce bone cuts errors. iAssist features simple and intuitive instrumentation that is based on conventional total knee arthroplasty instrumentation. iAssist should take less than 2-3 minutes (on average) to setup

Group Type: EXPERIMENTAL

iAssist Technique using Persona system vs. the conventional technique using Persona system

Intervention Type: PROCEDURE

Interventions

iAssist Technique using Persona system vs. the conventional technique using Persona system

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Male or female

2. Needs a primary TKR on the left or right knee

3. Diagnose of non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)

4. Over 18 years old

5. BMI>=30

6. Able to:

• Understand what participation in the study entails and give written informed consent, and
• Follow surgeon/staff instructions, and
• Return for all follow-up evaluations, and
• Able and willing to undergo a preoperative full-leg, standing radiographs (all cases)
• Willing to consent (patient or his/her legal guardian) to participate in the study by signing and dating an approved consent.
• Meet an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.

7. Presence of varus or valgus deformity of 15 degrees or less.

Exclusion Criteria

1. Currently enrolled in an investigational new drug or device study

2. Active Infection (including septic knee, distant infection, or osteomyelitis)

3. Severe hip arthrosis

4. Neurological disorders (including, but not limited to Parkinson's disease)

5. Prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy

6. Hip or knee ankylosis

7. Inflammatory joint disease.

8. Either rheumatoid or post-traumatic knee arthritis

9. Scheduled for simultaneous bilateral TKA

10. Indications of intra- and/or extra-articular deformations that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, such as polio, history of tibial plateau fracture, etc.

11. Any metal within 150 mm of the joint line for the operative-side knee

12. Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination

13. A female who is pregnant or lactating

14. Current involvement in any personal injury litigation, medical-legal or worker's compensation claims

15. Arterial disease or stents that would exclude the use of a tourniquet

16. Insufficient quality or quantity of bone to support the implant due to prior knee surgery (or surgeries), cancer, metabolic bone disease, osteoporosis/osteopenia (diagnosed or treated with medication), active/old/remote infection, etc.

17. Mental condition that may interfere with his/her ability to give an informed consent or interfere with his/her ability or willingness to fulfill the requirements of the study.

18. Condition that would place excessive demands on the implant (e.g., Charcot's joints, muscle deficiencies, multiple joint disabilities, skeletal immaturity, etc.).

19. Collateral ligament insufficiency.

20. Immunosuppressive disorder (e.g., AIDS, etc.) that would require cytotoxic drugs, corticosteroids, large dose of irradiation, or antilymphocytic serum.

21. An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Meir Libergall, Prof.

Role: CONTACT

liebergall@hadassah.org.il

972-2-6777111

Other Identifiers

0092-13-HMO

Identifier Type: -

Identifier Source: org_study_id