Reason for request

Inclusion

First assessment.

Unfavourable opinion for reimbursement in the repair of symptomatic cartilage defects of the knee (International Cartilage Repair Society classification grade III or IV) with defect sizes up to 10 cm2 in adults (for more details, see MA).

Role in the care pathway?

The therapeutic objectives are repair of damaged cartilage, improvement of functional performance and the patient’s quality of life, as well as prevention of osteoarthritis of the knee.

Medical treatment firstly includes adaptation of physical activities, weight loss if necessary, joint immobilisation, treatment of pain and rehabilitation.

Surgical treatment is only envisaged for symptomatic, grade III or IV knee cartilage defects in young patients, without ligament lesions or knee malalignment.

The choice of method depends on the size of the defect, the condition of the cartilage and the patient (age, weight, history, functional demand).

In France, the most commonly used methods are mosaicoplasty, microfractures (alone or with membrane cover) and osteochondral allograft. Mosaicoplasty is the reference technique for defects < 2 cm2. For these non-extensive defects, microfractures alone can also be used. The microfractures “plus” technique (combined with insertion of a membrane) is used for defects > 2 cm2 whereas the osteochondral allograft technique is reserved for very extensive (> 4 cm2) and deep defects.

Role of the medicinal product in the care pathway

On the basis of currently available data, SPHEROX has no role in the repair of cartilage defects of the knee with defect sizes up to 10 cm2 in adults.


Clinical Benefit

Insufficient

The clinical benefit of SPHEROX is insufficient in view of the available alternatives to justify its funding by the French national health insurance system in the MA indication.


Clinical Added Value

Not applicable

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