Multicenter Perspective Study: Clinical Evaluation of the Persona MC® With Preservation or Sacrifice of the PCL
NCT ID: NCT04244929
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2019-12-20
2021-03-01
Brief Summary
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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)
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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PCL removal
Patients will undergo surgery by sacrificing the PCL
Total knee arthroplasty
Total knee arthroplasty using standard anterior approach.
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice
Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be sacrificed
PCL preservation
Patients will undergo surgery with retaining the PCL
Total knee arthroplasty
Total knee arthroplasty using standard anterior approach.
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining
Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be retained
Interventions
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Total knee arthroplasty
Total knee arthroplasty using standard anterior approach.
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining
Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be retained
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice
Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be sacrificed
Eligibility Criteria
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Inclusion Criteria
1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
2. Collagen disorders and/or avascular necrosis of the femoral condyle
3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
4. Moderate valgus, varus, or flexion deformities
5. 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 unwilling or unable to give consent or to comply with the follow-up program.
* 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
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Principal Investigators
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Giulio Maria Marcheggiani Muccioli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Ortopedico Rizzoli
Locations
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IRCCS Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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Persona-MC
Identifier Type: -
Identifier Source: org_study_id
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