Multicenter Perspective Study: Clinical Evaluation of the Persona MC® With Preservation or Sacrifice of the PCL

NCT04244929 | Completed

• 1 other identifier: Persona-MC
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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)

Conditions

Prosthesis Survival

Outcome Measures

Primary Outcomes (1)

• 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)

  72 months

Secondary Outcomes (12)

• Evaluate the safety based on implant survivorship at 10 years follow up

  132 months

• Evaluation of pain

  132 months

• Evaluation of medication taken by the patient

  132 months

• Evaluation of muscle strength

  132 months

• Return to work

  132 months

Study Arms (2)

PCL removal

EXPERIMENTAL

Patients will undergo surgery by sacrificing the PCL

Procedure: Total knee arthroplasty; Device: Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice

PCL preservation

ACTIVE COMPARATOR

Patients will undergo surgery with retaining the PCL

Procedure: Total knee arthroplasty; Device: Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining

Interventions

Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining DEVICE

Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be retained

PCL preservation

Total knee arthroplasty PROCEDURE

Total knee arthroplasty using standard anterior approach.

PCL preservation; PCL removal

Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice DEVICE

Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be sacrificed

PCL removal

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (4)

• 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.

  PMID: 29326531 BACKGROUND

• 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.

  PMID: 27761443 BACKGROUND

• 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.

  PMID: 19844772 RESULT

• 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.

  PMID: 25381418 RESULT

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Giulio Maria Marcheggiani Muccioli, MD, PhD

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Co-Investigator who assesses the outcomes will be blind to the treatment group's allocation
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, two arms, multicenter study that aims to involve up to 10 hospitals in Italy

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 28, 2020
• Study Start: December 20, 2019
• Primary Completion: December 20, 2020
• Study Completion: March 1, 2021
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)