Clinical trial NCT04244929: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis Survival
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective, two arms, multicenter study that aims to involve up to 10 hospitals in Italy
Primary purpose: TREATMENT

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).

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:

  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 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

Primary outcomes:
measure: Evaluate the safety based on implant survivorship at 5 years follow up
timeFrame: 72 months
Secondary outcomes:
measure: Evaluate the safety based on implant survivorship at 10 years follow up
timeFrame: 132 months
measure: Evaluation of pain
timeFrame: 132 months
measure: Evaluation of medication taken by the patient
timeFrame: 132 months
measure: Evaluation of muscle strength
timeFrame: 132 months
measure: Return to work
timeFrame: 132 months
measure: Patient Satisfaction Questionnaire
timeFrame: 132 months
measure: Euro Quality of Life-5 Dimensions-5 Levels Health Questionnaire
timeFrame: 132 months
measure: Oxford Knee Score
timeFrame: 132 months
measure: American Knee Society Score
timeFrame: 132 months
measure: Forgotten Joint Score
timeFrame: 132 months
measure: Adverse Event Report
timeFrame: 132 months
measure: Explanted Device Form
timeFrame: 132 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
affiliation: IRCCS Istituto Ortopedico Rizzoli
name: Giulio Maria Marcheggiani Muccioli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.