Episurf Medical focuses on delivering solutions for active patients with focal chondral and osteochondral lesions, who have exhausted biological interventions. Using the latest personalised 3D technologies, Episurf offers a patient-specific technique based on detailed MRI sequencing that is customised to each patient’s unique situation and anatomy.
Focal chondral and osteochondral lesions can have a huge impact on the life of your patient. For middle-aged patients, biological treatments such as microfracture, mosaicplasty and (M)ACI, can lead to unsatisfactory results and knee arthroplasty might be undesirable due to the risk of loosening and revision. Episealer® from Episurf Medical is a patient-specific resurfacing implant to treat focal cartilage lesions and underlying bone defects in the knee joint, tailoring the transition between biological treatments and knee arthroplasty. It is designed to stop or delay the need for joint replacement surgery and restore normal function and a life with significantly less pain for your patient.
Magnetic Resonance Imaging and the specific Episurf protocol
The Episealer implant and the Epiguide® surgical tool are designed based on MRI data. Using tailored 3D segmentations as well as conventional 2D diagnostic sequences, a detailed profile of the patient’s knee is produced. This profile is used to precisely assess all aspects of the patient’s chondral and osteochondral defects as well as the patient’s own knee geometry.
Damage Marking Report
From the detailed MRI of the patient’s knee, an extensive file is created called a damage marking report (DMR). This report will help you in the decision-making process and the surgical pre-planning.
It contains a 3D visualisation of the patient’s knee with all chondral, osteochondral and bone marrow lesions (BML) mapped and it suggests a treatment solution. This will enable you to view and explore the knee injury and potential implant placement. The 3D-interactive presentation of the patient’s unique disease process is presented in an easy-to-understand and simple-to-visualise format, allowing pre-surgical 3D-analysis of every patient’s unique situation.
Episealer, Epiguide and the custom-made toolkit
After approval of the proposed solution, patient-specific surgical instruments are precisely engineered based on the MRI sequences.
The Episealer is uniquely designed to fit the patient´s individual cartilage and bone damage, in size and depth, as well as location. It consists of both peg and hat in a one-piece, monolithic design, made of a cobalt-chrome alloy with a polished top surface. A titanium and hydroxyapatite coating is applied to the areas that will interdigitate with the host tissue.
The Episealer comes in 3 versions, based on the placement in the knee:
- Episealer Condyle Solo for lesions in the medial or lateral condyle
- Episealer Trochlea Solo for lesions in the trochlea area
- Episealer Femoral Twin for lesions in both condyles and/or trochlea
It is available in following sizes:
- Episealer Condyle Solo: 12mm, 15mm, 17mm and 20mm diameter
- Episealer Trochlea Solo: 20mm, 25mm and 29mm diameter
- Episealer Femoral Twin: 2x15mm (total length: 23mm), 2x17mm (total length: 26mm), 2x20mm (total length: 29mm) and 2x25mm (total length: 35mm)
The Episealer comes with a custom-made Epiguide, designed to fit the patient’s knee. It will guide you through the surgery and ensures a perfect placement of the Episealer.
The Episealer is delivered with a 7-piece toolkit that contains all necessary instruments to optimally utilise all benefits of the Epiguide.
The rehabilitation programme is determined by the doctor/physiotherapist but it is usually recommended to protect weight-bearing for 3 days after surgery. Subsequently, the load is increased gradually. The rehabilitation will be the same as what is recommended for post-operative care of other resurfacing prostheses. After the rehabilitation period there are no precautions to be taken during normal daily activities. If the patient experiences persistent pain, not related to the healing process, a doctor should be consulted. The patient should be informed and monitored to ensure adherence to post-operative instructions and activity restrictions and limitations.
The Episealer is intended for patients with a focal knee chondral or osteochondral lesion, causing pain and/or disability. The patient has a history of failed conservative treatment and has a lesion requiring surgical treatment.
Absolute contraindications include:
- Non-focal defects
- Patellofemoral instability or malalignment that is uncorrectable at the time of treatment
- On-going infection in the knee joint
- Inflammatory arthritis or radiographic osteoarthritis
- Sensitivity to materials typically used in orthopaedic prosthetics
- Inadequate bone stock where the Episealer is to be inserted
- Existing prosthesis in area of treatment or opposing surface
- Severe lesion (ICRS 3-4) on opposing tibial (in case of Condyle Solo/Femoral Twin)/patellar (in case of Trochlea Solo/Femoral Twin) surface
Relative contraindications include:
- Patella maltracking or instability (in case of Trochlea Solo/Femoral Twin for trochlear lesions)
- Pain of unknown etiology
- Other diseases or medication that may affect the bone anchoring of the Episealer
- Uncooperative patient that is not willing to follow instructions
- Muscular insufficiency
- Vascular insufficiency
- Medical, hormonal, haematological, immunological and metabolic illnesses
- Demineralised bone
Possible Adverse Effects
General surgical complications:
- General knee surgery risks such as local swelling, temporary soreness, joint exudate, haematoma, thrombosis, inflammation, early or late postoperative infection in the operation area and bleeding
- Complications related to anaesthesia
Adverse effects related to the Episealer:
- Intraoperative or postoperative bone fracture
- Allergic reaction
- Loosening, migration or loss of fixation of the Episealer
- Wear and damage to the opposed articular cartilage surface
For more information regarding Episealer and available references, please visit www.episurf.com or contact us on firstname.lastname@example.org.
Episealer Condyle Solo, Trochlea Solo and Femoral Twin are CE-marked and licensed for use within the European Union.
The Episurf simulations on the Touch Surgery platform are intended for promotion and user education only and therefore not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating a health professional’s assessment of a specific patient, replacing the judgment of clinical personnel, or performing any clinical assessment.
The Episurf simulations on the Touch Surgery platform are only a part of the Episurf Surgeon Education programme. Completing the simulation on the Touch Surgery platform alone does not provide sufficient skills to perform the Episealer procedure. Contact Episurf for more information regarding training opportunities.