Evaluation of the Triamcinolone -Acetonide Therapy for the Treatment of the Medial Plica Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Eco-guided Treatment With Triamcinolone-Acetonide in the Treatment of Medial Plica Syndrome - A Pilot Study

Conditions
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Medial Plica Syndrome

Intervention / Treatment
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* Procedure: Eco-guided Triamcinolone-Acetonide injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ultrasonographic and/or MRI signs of medial plica pathology; VAS pain 4-8 at time of inclusion; Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment of at least 6 weeks (rest and drug treatment, physiotherapy); Ability and consent of patients to actively participate in clinical follow-up; Exclusion Criteria: BMI > 35; Patients with: rheumatic diseases, diabetes, infectious processes, epilepsy, severe stage osteoporosis Patients undergoing intra-tendon infiltration of other substance within the previous 6 months; Patients undergoing surgery on the affected knee within the previous 12 months; Patients undergoing femoro- patellar joint stabilization surgery to the affected knee; Trauma to the affected knee within the past 6 months; Episodes of patellar dislocation and subluxation to the affected knee; State of immunodepression; Ongoing systemic inflammatory diseases (stabilized outcomes of these diseases are not considered absolute contraindications). Contraindications to use or hypersensitivity to the active ingredient (Triamcinolone Acetonide) or to the excipients (sodium chloride, benzyl alcohol, sodium carboxymethylcellulose, polysorbate 80 and water for injectable preparations)found within Kenacort as per the product package insert; 12. Contraindications or hypersensitivity to the active ingredient of the local anesthetic (Lidocaine) or their excipients; 13. Pregnancy or lactation status or intention to become pregnant during the period of study participation. In particular, in the case of a suspected pregnancy , this will be excluded by serological testing (hCG).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The pilot study will be include a single group of 30 patience affected by the medial plica syndrome. Patients will be treated with an eco-guided injection of Triamcinolone-Acetonide and will be evaluated clinical and radiological outcomes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eco-guided Triamcinolone-Acetonide injection<br>Patients affected by medial plica syndrome will be treated with an eco-guided injection of Triamcinolone-Acetonide. | Procedure: Eco-guided Triamcinolone-Acetonide injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months FU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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. | 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; | baseline, 1 month, 3 months FU | 
| MRI assessment | This assessment is useful for evaluating plica retraction | baseline, 6 months FU | 
| 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. | 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 yesor no regarding the rehabilitation. | 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, medial plica syndrome, medial plica, Pilot study, Triamcinolone Acetonide, injection treatment