Zimmer POLAR - Total Knee Arthroplasty (TKA)

RheumatoId Arthritis Clinical Trial

Official title:

Persona Outcomes Led Assessment Research in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859130
• Other study ID #: CSU2012-10K
• Status: Completed
• Phase: N/A
• Start date: October 21, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Polyarthritis
• RheumatoId Arthritis
• Traumatic Arthritis

Intervention

Device:
• Zimmer Persona Total Knee System

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	The Rothman Institute	Egg Harbor Township	New Jersey
United States	Midwest Orthopaedics at Rush	Naperville	Illinois
United States	The Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EQ-5D	The EQ-5D family of instruments has been developed to evaluate health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health. The overall range is -0.1 to 1.0. A higher score indicates a better overall health rating reported by the patient, and a lower score indicates a poor overall health rating. It is possible to score a negative value. Although unlikely, a negative value is observed to be a state worse than death.	5 years post op
Secondary	Forgotten Joint Score (FJS)	The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty (TKA). Scores range from 0-100. A score of 100 would indicate a high degree of "forgetting" the artificial joint (a low degree of awareness). A score of 0 would indicates a very low degree of "forgetting" the artificial joint (typically aware of the replacement).	5 years post-op