The aim of this pilot study is to evaluate the clinical and radiological outcomes (ultrasound and MRI) for a treatment utilized in the medial plica syndrome resistant to conservative therapy. Will be evaluated an intra-plica ultrasound-guided injections of Triamcinolone-Acetonide and lidocaine percutaneously, and associated rehabilitation therapy. The aim of the study will be to evaluate the efficacy and safety of the injection procedure by revealing clinical improvement and monitoring the incidence of adverse events following treatment.
30 patients affected by the medial plica syndrome will be included in a pilot study in which one will be evaluated the effect of treatment with Triamcinolone-Acetonide and Lidocaine, injected intraplical with an ultrasound-guided procedure. For evaluating the treatment, will be considered functional and pain outcomes. Patients will be evaluated before treatment by a clinical, an MRI and an ultrasound examination. After the injection, they will be followed up at 1, 3, 6 and 12 months. At the 1 and 3 month FU visits patients will be evaluated by an ultrasound examination and at the 6 month FU they will be evaluated by an MRI examination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The treatment consists in injecting 1 ml of Kenacort (corresponding to 40 mg of Triamcinolone Acetonide) diluted in about 1 ml of local anesthetic (Lidocaine) directly into the medial fold of the knee. Through an ultrasound guidance with "in plane" technique, the flute beak of the needle will be positioned between the two sheets of the synovial fold and the injection will be performed.
Istituto Ortopedico Rizzoli
Bologna, Italy
KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS
This is a patient-reported assessment of patellofemoral disorders that evaluates subjective symptoms and functional limitations. The evaluation consist of 13 questions with a total score of 100 points.
Time frame: 6 months FU
KOOS (Knee Injury and Osteoarthritis Outcome Score)
KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items).
Time frame: baseline, 1 month, 3 months, 6 and 12 months FU
VAS (Visual Analogue Scale)
VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable
Time frame: baseline, 1 month, 3 months, 6 and 12 months FU
Patient Acceptable Symptom State (PASS)
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no".
Time frame: baseline, 1 month, 3 months, 6 and 12 months, 24 months FU
Ultrasound assessment
This examination is useful to evaluate the evolution of plica thickness;
Time frame: baseline, 1 month, 3 months FU
MRI assessment
This assessment is useful for evaluating plica retraction
Time frame: baseline, 6 months FU
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Final treatment opinion
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".
Time frame: 24 months follow-up
Patient Rehabilitation Monitoring
The patient will be asked if he/she performs the planned rehabilitation activity for the 12 weeks following treatment. All patients will be able to answer "yes"or "no" regarding the rehabilitation.
Time frame: 12 months follow-up