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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Medial Plica Syndrome

Treatments: Procedure: Eco-guided Triamcinolone-Acetonide injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04943341

PLICA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ultrasonographic and/or MRI signs of medial plica pathology;
2. VAS pain 4-8 at time of inclusion;
3. 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);
4. Ability and consent of patients to actively participate in clinical follow-up;

Exclusion criteria

1. BMI > 35;
2. Patients with: rheumatic diseases, diabetes, infectious processes, epilepsy, severe stage osteoporosis
3. Patients undergoing intra-tendon infiltration of other substance within the previous 6 months;
4. Patients undergoing surgery on the affected knee within the previous 12 months;
5. Patients undergoing femoro- patellar joint stabilization surgery to the affected knee;
6. Trauma to the affected knee within the past 6 months;
7. Episodes of patellar dislocation and subluxation to the affected knee;
8. State of immunodepression;
9. Ongoing systemic inflammatory diseases (stabilized outcomes of these diseases are not considered absolute contraindications).
10. 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Eco-guided Triamcinolone-Acetonide injection

Experimental group

Description:

Patients affected by medial plica syndrome will be treated with an eco-guided injection of Triamcinolone-Acetonide.

Treatment:

Procedure: Eco-guided Triamcinolone-Acetonide injection