iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty

NCT03111407 | Completed Results

• 1 other identifier: CSE2012-05K
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to radiographic, clinical and economic outcomes and compared to conventional instrumentation in primary total knee arthroplasty (NexGen or Persona knee implants).

Conditions

Avascular Necrosis; Post-traumatic; Arthrosis; Knee Osteoarthritis

Keywords

primary total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Component Alignment

  Assess the differences in component alignment, measured by the mean of radiographs, between iASSIST™ and conventional instrumentation in primary total knee arthroplasty (TKA) procedures.

  1 year

Secondary Outcomes (3)

• Knee Society Score Assessment

  1 year

• Knee Society Score Function

  1 year

• EQ-5D Questionnaire

  1 year

Study Arms (2)

iAssist group

OTHER

patients will have primary total knee arthroplasty with the iAssist. The iAssist Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and implant components relative to these axes.

Procedure: total knee arthroplasty

conventional instrumentation

OTHER

patients will have primary total knee arthroplasty with the conventional instrumentation.

Procedure: total knee arthroplasty

Interventions

total knee arthroplasty PROCEDURE

surgical procedure in which damaged parts of the knee joint are replaced with an implant.

conventional instrumentation; iAssist group

Eligibility Criteria

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

You may qualify if:

• Patient is male or female
• Patient needs a primary total knee replacement using the NexGen LPS Flex or Persona knee implant
• Patient is diagnosed with non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)
• Patient is over 18 years old
• Patient is able to:
• Understand what participation in the study entails and willing to consent (patient or his/her legal guardian) to participate in the study by signing and dating an IRB/EC (ethics committee) approved inform consent form, and
• Follow surgeon/staff instructions, and
• Return for all follow-up evaluations, and
• Able and willing to undergo a preoperative full-leg, standing radiographs and/or CT-scan
• Patient meets an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
• Patient has a presence of varus or valgus deformity of 15 degrees or less.

You may not qualify if:

• Patient is currently enrolled in an investigational new drug or device study.
• Patient has an active infection (including septic knee, distant infection, or osteomyelitis).
• Patient has severe hip arthrosis.
• Patient has neurological disorders (including, but not limited to Parkinson's disease).
• Patient has had a prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy.
• Patient has hip or knee ankylosis.
• Patient has inflammatory joint disease.
• Patient has rheumatoid knee arthritis.
• Patient has 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.
• Patient has any metal within 150 mm of the joint line for the operative-side knee.
• Patient has knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination.
• Female who is pregnant or lactating.
• Patient currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Patient has arterial disease or stents that would exclude the use of a tourniquet.
• Patient has 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.

Sponsors & Collaborators

• Zimmer, GmbH: lead

Study Sites (3)

Hospital El Angel, S.A.

Málaga, 29007, Spain

Location

Hospital Unviersitario Son Espases

Palma de Mallorca, 07010, Spain

Location

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Osteonecrosis; Osteoarthritis; Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Since the first follow-up visits were performed according to the standard of care of each site, they did not occur at the same time point.

Results Point of Contact

• Title: Emilie Rohmer, Clinical Operations Manager
• Organization: Zimmer Biomet

Emilie.Rohmer@zimmerbiomet.com

+41 58 85 48210

Study Officials

• Paola Vivoda, Ass.Direct

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study patients will not know if their knee prosthesis will be implanted with iAssist or with conventional instrumentation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 groups of patients: 1 will have the knee prosthesis implanted with iAssist and the other with conventional instrumentation.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: April 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); ES (2)