Multicenter Perspective Study: Clinical Evaluation of the Persona MC® With Preservation or Sacrifice of the PCL
Primary Purpose
Prosthesis Survival
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Total knee arthroplasty
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice
Sponsored by
About this trial
This is an interventional treatment trial for Prosthesis Survival
Eligibility Criteria
Inclusion Criteria:
Patient qualifies for a 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 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 MC knee implants. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- Patient has participated in the Informed Consent process and has signed the Ethics Committee approved 'Informed Consent'.
Exclusion Criteria:
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient meets exclusion criteria of the Instruction for Use Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
- 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
Sites / Locations
- IRCCS Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PCL removal
PCL preservation
Arm Description
Patients will undergo surgery by sacrificing the PCL
Patients will undergo surgery with retaining the PCL
Outcomes
Primary Outcome Measures
Evaluate the safety based on implant survivorship at 5 years follow up
Implant survival will be evaluated by radiographic parameters on standard and long leg standing radiographs that indicate prosthesis mobilization (radiolucency lines, fracture, osteolysis)
Secondary Outcome Measures
Evaluate the safety based on implant survivorship at 10 years follow up
Implant survival will be evaluated by radiographic parameters on standard and long leg standing radiographs that indicate prosthesis mobilization (radiolucency lines, fracture, osteolysis)
Evaluation of pain
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to pain (VAS scale).
Evaluation of medication taken by the patient
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to medications.
Evaluation of muscle strength
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to muscle strength, evaluated with a subjective scale by the investigator
Return to work
Additional information regarding the returning of the patient to work is collected at 3 or 6 months follow up
Patient Satisfaction Questionnaire
It is a patient-reported short questionnaire for evaluating patient satisfaction with the knee replacement surgery
Euro Quality of Life-5 Dimensions-5 Levels Health Questionnaire
It is completed by the patient and assesses his/her general health status. The EQ-5D is used to derive a quality of life index used for health economics considerations
Oxford Knee Score
It is a patient-reported form and consists of 12 questions on the influence of the knee (surgical side) on daily activities or pain.
American Knee Society Score
It is used to assess knee functionality by investigator. It consists of both a clinical and a functional score
Forgotten Joint Score
is completed by the patient and assesses his/her ability to forget about his/ her knee joint prior and after treatment
Adverse Event Report
is completed as needed for each complication which is noted. Each complication shall be examined again at the next follow-up visit and further documented on a separate form for each visit.
Explanted Device Form
collects information on revision surgeries for study subjects.
Full Information
NCT ID
NCT04244929
First Posted
January 20, 2020
Last Updated
May 29, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT04244929
Brief Title
Multicenter Perspective Study: Clinical Evaluation of the Persona MC® With Preservation or Sacrifice of the PCL
Official Title
Clinical Evaluation of the Total Knee Prosthesis Persona Medial Congruent® With Preservation or Sacrifice of the Posterior Cruciate Ligament: a Multicentric Perspective Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee".
Primary endpoint
-Evaluation of the survival of the implant after 5 years of follow-up
Secondary endpoints
Evaluation of the survival of the implant at 10 years of follow up.
Evaluation of clinical and radiographic outcomes in Italian patients undergoing total knee replacement with the Persona Medial Congruent® implant with sacrifice or retention of the posterior cruciate ligament (PCL)
Detailed Description
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee" Up to 10 Italian centers will provide a maximum of 200 patients undergoing total knee replacement with Persona prosthesis and Medial Congruent® insert.
20 cases per center will be performed, 10 with posterior cruciate ligament sacrifice, 10 with posterior cruciate ligament preservation.
Patients will be recruited and enrolled in the study according to the inclusion and exclusion criteria specified below. In order to minimize the selection bias, patients will be enrolled consecutively; the first 10 patients will constitute a treatment group and the remaining 10 the complementary group.
Each patient will sign an informed consent for participation in the prospective study. The patients will be recruited at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute on an outpatient or hospitalization basis.
After the surgical treatment, the patient will continue his hospitalization at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute and, if deemed appropriate by the medical team, he will be discharged by planning the subsequent post-operative checks and diagnostic evaluations.
The data will be collected by investigators and provided to the Promoter center.
The Co-investigator who will evaluate the results will be blind to the assignment to the treatment group of the subjects in the study. The promoter of the study is the owner of the data and therefore responsible for data management. Study participants are identified with an identification code. All sensitive personal data will be stored in accordance with the current data privacy guidelines. All information will be treated with strict compliance with professional confidentiality standards. Participants will receive oral and written information relating to the processing of sensitive personal data.
The study is designed to have an alpha error of no more than 0.05. Based on an assumed 95% five-year survival, a sample size of n = 89 was calculated using SAS 9.4, Proc Power.
Assuming a 20% follow-up loss rate over five years, the study will enroll 100 patients in each patient group, then a total of 200 patients. The data collected from 200 patients (100 in each subgroup) will be archived in a descriptive way and will be the basis of all published study reports.
The categorical data (for example, gender) will be summarized using counts, percentages and the 95% confidence interval (CI), in the periods of interest. Continuous data, such as age, will be summarized using means, medians, standard deviation, minimum, maximum and 95% CI in the periods of interest. Implant survival and return to function will be summarized using the Kaplan-Meier method and presented as percentages and confidence intervals.
The expected duration of the study is 11 years, which corresponds to the time dedicated to the approval of the Ethics Committee, the enrollment of all patients, the completion of the 10-year follow-up, data analysis and preparation of the final report. The first 12 months will focus on patient enrollment. The study subjects will be involved from the moment of the intervention until the end of the 10-year follow-up (as per the current protocol 10 years FU ± 2 months).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Prospective, two arms, multicenter study that aims to involve up to 10 hospitals in Italy
Masking
Outcomes Assessor
Masking Description
The Co-Investigator who assesses the outcomes will be blind to the treatment group's allocation
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCL removal
Arm Type
Experimental
Arm Description
Patients will undergo surgery by sacrificing the PCL
Arm Title
PCL preservation
Arm Type
Active Comparator
Arm Description
Patients will undergo surgery with retaining the PCL
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
Total knee arthroplasty using standard anterior approach.
Intervention Type
Device
Intervention Name(s)
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining
Intervention Description
Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be retained
Intervention Type
Device
Intervention Name(s)
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice
Intervention Description
Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be sacrificed
Primary Outcome Measure Information:
Title
Evaluate the safety based on implant survivorship at 5 years follow up
Description
Implant survival will be evaluated by radiographic parameters on standard and long leg standing radiographs that indicate prosthesis mobilization (radiolucency lines, fracture, osteolysis)
Time Frame
72 months
Secondary Outcome Measure Information:
Title
Evaluate the safety based on implant survivorship at 10 years follow up
Description
Implant survival will be evaluated by radiographic parameters on standard and long leg standing radiographs that indicate prosthesis mobilization (radiolucency lines, fracture, osteolysis)
Time Frame
132 months
Title
Evaluation of pain
Description
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to pain (VAS scale).
Time Frame
132 months
Title
Evaluation of medication taken by the patient
Description
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to medications.
Time Frame
132 months
Title
Evaluation of muscle strength
Description
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to muscle strength, evaluated with a subjective scale by the investigator
Time Frame
132 months
Title
Return to work
Description
Additional information regarding the returning of the patient to work is collected at 3 or 6 months follow up
Time Frame
132 months
Title
Patient Satisfaction Questionnaire
Description
It is a patient-reported short questionnaire for evaluating patient satisfaction with the knee replacement surgery
Time Frame
132 months
Title
Euro Quality of Life-5 Dimensions-5 Levels Health Questionnaire
Description
It is completed by the patient and assesses his/her general health status. The EQ-5D is used to derive a quality of life index used for health economics considerations
Time Frame
132 months
Title
Oxford Knee Score
Description
It is a patient-reported form and consists of 12 questions on the influence of the knee (surgical side) on daily activities or pain.
Time Frame
132 months
Title
American Knee Society Score
Description
It is used to assess knee functionality by investigator. It consists of both a clinical and a functional score
Time Frame
132 months
Title
Forgotten Joint Score
Description
is completed by the patient and assesses his/her ability to forget about his/ her knee joint prior and after treatment
Time Frame
132 months
Title
Adverse Event Report
Description
is completed as needed for each complication which is noted. Each complication shall be examined again at the next follow-up visit and further documented on a separate form for each visit.
Time Frame
132 months
Title
Explanted Device Form
Description
collects information on revision surgeries for study subjects.
Time Frame
132 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient qualifies for a 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 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 MC knee implants. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
Patient has participated in the Informed Consent process and has signed the Ethics Committee approved 'Informed Consent'.
Exclusion Criteria:
Patient is currently participating in any other surgical intervention studies or pain management studies
Patient is unwilling or unable to give consent or to comply with the follow-up program.
Patient meets exclusion criteria of the Instruction for Use Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulio Maria Marcheggiani Muccioli, MD, PhD
Organizational Affiliation
IRCCS Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29326531
Citation
Sabatini L, Risitano S, Parisi G, Tosto F, Indelli PF, Atzori F, Masse A. Medial Pivot in Total Knee Arthroplasty: Literature Review and Our First Experience. Clin Med Insights Arthritis Musculoskelet Disord. 2018 Jan 4;11:1179544117751431. doi: 10.1177/1179544117751431. eCollection 2018.
Results Reference
background
PubMed Identifier
27761443
Citation
Van Overschelde PP, Fitch DA. Patient satisfaction at 2 months following total knee replacement using a second generation medial-pivot system: follow-up of 250 consecutive cases. Ann Transl Med. 2016 Sep;4(18):339. doi: 10.21037/atm.2016.08.41.
Results Reference
background
PubMed Identifier
19844772
Citation
Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
Results Reference
result
PubMed Identifier
25381418
Citation
Nam D, Nunley RM, Barrack RL. Patient dissatisfaction following total knee replacement: a growing concern? Bone Joint J. 2014 Nov;96-B(11 Supple A):96-100. doi: 10.1302/0301-620X.96B11.34152.
Results Reference
result
Learn more about this trial
Multicenter Perspective Study: Clinical Evaluation of the Persona MC® With Preservation or Sacrifice of the PCL
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