Zimmer POLAR - Total Knee Arthroplasty (TKA)

NCT ID: NCT01859130

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-21
• Study Completion Date: 2021-12-31

Brief Summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.

Detailed Description

The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain Institutional Review Board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.

All info specified in the Brief Summary will be captured via the Knee Society Score, EQ-5D, Forgotten Joint Score, KSS Patient Expectations, Physical Exam, and Physician's Assessment of Radiographic Outcomes form.

Conditions

Osteoarthritis; RheumatoId Arthritis; Traumatic Arthritis; Polyarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Persona TKA

Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System

Group Type: OTHER

Zimmer Persona Total Knee System

Intervention Type: DEVICE

Interventions

Zimmer Persona Total Knee System

Intervention Type: DEVICE

Other Intervention Names

Primary Knee Replacement,; Total Knee Arthroplasty,; Total Knee Replacement

Eligibility Criteria

Inclusion Criteria

• Patient 18-75 years of age, inclusive;
• Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

• rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
• collagen disorders and/or avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus, or flexion deformities;
• the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee;
• Patient has participated in a study-related Informed Consent process;
• Patient is willing and able to complete scheduled study procedures and follow-up evaluations;
• Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling.

Exclusion Criteria

• Patient is currently participating in any other surgical intervention studies or pain management studies;
• Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint;
• Insufficient bone stock on femoral or tibial surfaces;
• Skeletal immaturity;
• Neuropathic arthropathy;
• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
• Stable, painless arthrodesis in a satisfactory functional position;
• Severe instability secondary to the absence of collateral ligament integrity;
• Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin;
• Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.);
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kacy Arnold, RN MBA

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Midwest Orthopaedics at Rush

Naperville, Illinois, United States

The Rothman Institute

Egg Harbor, New Jersey, United States

Duke University

Durham, North Carolina, United States

The Rothman Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSU2012-10K

Identifier Type: -

Identifier Source: org_study_id