Zimmer POLAR - Total Knee Arthroplasty (TKA)

NCT01859130 | Completed Results FDA Device

• 1 other identifier: CSU2012-10K
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoarthritis; RheumatoId Arthritis; Traumatic Arthritis; Polyarthritis

Outcome Measures

Primary Outcomes (1)

• Knee Society Scores

  This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain.

  5 years post op

Secondary Outcomes (2)

• EQ-5D

  5 years post op

• Forgotten Joint Score (FJS)

  5 years post-op

Study Arms (1)

Persona TKA

OTHER

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

Device: Zimmer Persona Total Knee System

Interventions

Zimmer Persona Total Knee System DEVICE

Also known as: Primary Knee Replacement,, Total Knee Arthroplasty,, Total Knee Replacement

Persona TKA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Midwest Orthopaedics at Rush

Naperville, Illinois, 60563, United States

Location

The Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Arthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: Zimmer Biomet

tim.swanson@zimmerbiomet.com

5745497606

Study Officials

• Kacy Arnold, RN MBA

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 21, 2013
• Study Start: October 21, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 13, 2023
• Results First Posted: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)