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

NCT02117973 | Unknown Phase 2

• 1 other identifier: 0092-13-HMO
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• differences in limb alignment

  The primary endpoint is defined as Limb alignment as determined using radiographs (A/P long-standing and lateral films)

  12 MONTHS

Secondary Outcomes (1)

• difference in Knee Society Score

  12 MONTHS

Other Outcomes (3)

• difference in Oxford knee score

  12 months

• Operating room time

  three hours

• Blood loss and complications

  12 months

Study Arms (2)

Conventional Technique using Persona prosthesis

ACTIVE COMPARATOR

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.

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

iAssist Technique using Persona prosthesis

EXPERIMENTAL

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

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

Interventions

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

Conventional Technique using Persona prosthesis; iAssist Technique using Persona prosthesis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Needs a primary TKR on the left or right knee
• Diagnose of non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)
• Over 18 years old
• BMI\>=30
• 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.
• Presence of varus or valgus deformity of 15 degrees or less.

You may not qualify if:

• Currently enrolled in an investigational new drug or device study
• Active Infection (including septic knee, distant infection, or osteomyelitis)
• Severe hip arthrosis
• Neurological disorders (including, but not limited to Parkinson's disease)
• Prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
• Hip or knee ankylosis
• Inflammatory joint disease.
• Either rheumatoid or post-traumatic knee arthritis
• Scheduled for simultaneous bilateral TKA
• 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.
• Any metal within 150 mm of the joint line for the operative-side knee
• Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
• A female who is pregnant or lactating
• Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
• Arterial disease or stents that would exclude the use of a tourniquet

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Central Study Contacts

Meir Libergall, Prof.

CONTACT

972-2-6777111; liebergall@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: April 21, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Last Updated: April 21, 2014

Record last verified: 2014-02