The project will investigate safety, feasibility and efficiency when using Episurf Episeal talus implant in patients with osteochondral ankle injuries. Assessments includes revision rate, complications, pain, function and quality of life over two years. Ten patients (aged 20-60) who have not responded to previous treatment will participate based on informed and written consent. The project uses a prospective cohort design where the patients receive a customized surgical procedure. Data on clinical function, pain and patient satisfaction collected using the AOFAS ankle score, NRS and EQ-5D-5L questionnaire at 6 weeks, 6 months, 1 year and 2 years after the operation. The study can provide valuable insight into the treatment of ankle osteoarthritis, improve the patient's quality of life and function, and represent a step forward in orthopedic surgery, especially for younger, active patients. The results are shared with it the medical community and the general public through publications and presentations.
Patients aged 20-60 years with symptomatic osteochondral lesions of the ankle where conservative treatment or previous surgery has been unsatisfactory.
Patients with a limited cartilage defect that qualifies for Episealer implantation.
Patients who have provided written informed consent to participate in the study.
Patients with an active infection in the ankle.
Patients with extensive cartilage damage where Episealer is not indicated.
Patients with osteoarthritic changes on the tibial side of the ankle joint.
Patients with severe joint instability.
Single group
Talus prosthesis
Procedure/SurgeryThe Episealer Talus is an individualised resurfacing implant intended for use on either the medial or lateral talus. It aims to treat patients suffering from pain and reduced mobility due to focal osteochondral lesions in the talus.
Number of patients undergoing revision surgery
Revision surgery involves replacing or removing part or all of the talus prosthesis. This may be necessary in the event of various problems with the prosthesis, for example that the prosthesis has loosened from the bone, wear of the prosthesis materials, infection or if the prosthesis dislocates.
Patient satisfaction on a scale from 0 to 10
Patient satisfaction is assessed by the use of NRS, or Numerical Rating Scale, which is a widely used method for assessing patients' experience of satisfaction. It consists of a scale from 0 to 10, where 0 represents or "completely dissatisfied" and 10 indicates "completely satisfied". Patients are asked to rate their satisfaction level by selecting a number that best describes their current condition. The NRS is easy to administer and understand, and can be used in a number of medical and research contexts to quantify degree of satisfaction. This method is particularly useful for following changes in the patient's condition over time, as well as evaluating the effect of treatments or interventions. In assessments of satisfaction, the person answers a standard question from the project staff. The NRS has been found to be both reliable and valid and is widely used when assessing satisfaction.
Patient pain on a scale from 0 to 10
Pain is assessed by the use of NRS, or Numerical Rating Scale, which is a widely used method for assessing patients' experience of pain. It consists of a scale from 0 to 10, where 0 represents "no pain" and 10 indicates "worst imaginable pain". Patients are asked to rate their pain level by selecting a number that best describes their current condition. The NRS is easy to administer and understand, and can be used in a number of medical and research contexts to quantify pain intensity. This method is particularly useful for following changes in the patient's condition over time, as well as evaluating the effect of treatments or interventions. In assessments of pain, the person answers a standard question from the project staff. The NRS has been found to be both reliable and valid and is widely used when assessing pain.
AOFAS ankle score on a scale from 0 to 100
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points. This score may be used to assess the ankle, subtalar, talonavicular, and calcaneocuboid joint levels and may be useful for fractures, arthroplasty, arthrodesis, and instability procedures.
EQ-5D-5L score
The EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) is a generic tool for Patient-Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
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