Clinical trial NCT01859130: Zimmer POLAR - Total Knee Arthroplasty (TKA)
Official title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
RheumatoId Arthritis
Traumatic Arthritis
Polyarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Knee Society Scores
timeFrame: 5 years post op
Secondary outcomes:
measure: EQ-5D
timeFrame: 5 years post op
measure: Forgotten Joint Score (FJS)
timeFrame: 5 years post-op
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Egg Harbor Township
country: United States
facility: The Rothman Institute
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold, RN MBA
role: STUDY_DIRECTOR
References: