Osteoarthritis, Polyarthritis, RheumatoId Arthritis, Traumatic Arthritis
Conditions
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.
Interventions
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Scores | 5 years post op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | 5 years post op | 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. |
| Forgotten Joint Score (FJS) | 5 years post-op | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Persona TKA Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System | 299 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Sponsor terminated: 47 Not specified: 3 | 53 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Persona TKA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 146 Participants |
| Age, Categorical Between 18 and 65 years | 153 Participants |
| Age, Continuous | 62.88 years |
| EQ5D-5L | 0.5 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 296 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Knee Society Score - Objective Knee | 47.3 units on a scale |
| KSS Patient Expectations | 14.4 units on a scale |
| Region of Enrollment United States | 299 participants |
| Sex: Female, Male Female | 157 Participants |
| Sex: Female, Male Male | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 299 |
| other Total, other adverse events | 227 / 299 |
| serious Total, serious adverse events | 72 / 299 |
Outcome results
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.
Time frame: 5 years post op
Population: Only 161 subjects completed the KSS form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Persona TKA | Knee Society Scores | 92.9 units on a scale |
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.
Time frame: 5 years post op
Population: Only 175 subjects completed the EQ-5D form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Persona TKA | EQ-5D | 0.9 units on a scale |
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).
Time frame: 5 years post-op
Population: Only 176 subjects completed the FJS form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Persona TKA | Forgotten Joint Score (FJS) | 74.9 units on a scale |