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

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Recruiting

CT.gov ID

NCT04943341

Collaborator

(none)

Enrollment

Location

Arm

20.1

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Medial Plica Syndrome	Procedure: Eco-guided Triamcinolone-Acetonide injection	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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 outcomesThe 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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 28, 2021

Actual Primary Completion Date :

Apr 27, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eco-guided Triamcinolone-Acetonide injection Patients affected by medial plica syndrome will be treated with an eco-guided injection of Triamcinolone-Acetonide.	Procedure: Eco-guided Triamcinolone-Acetonide injection 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.

Arm

Intervention/Treatment

Experimental: Eco-guided Triamcinolone-Acetonide injection

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

Procedure: Eco-guided Triamcinolone-Acetonide injection

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.

Outcome Measures

Primary Outcome Measures

KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS [6 months FU]
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.

Secondary Outcome Measures

KOOS (Knee Injury and Osteoarthritis Outcome Score) [baseline, 1 month, 3 months, 6 and 12 months FU]
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).
VAS (Visual Analogue Scale) [baseline, 1 month, 3 months, 6 and 12 months FU]
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
Patient Acceptable Symptom State (PASS) [baseline, 1 month, 3 months, 6 and 12 months, 24 months FU]
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".
Ultrasound assessment [baseline, 1 month, 3 months FU]
This examination is useful to evaluate the evolution of plica thickness;
MRI assessment [baseline, 6 months FU]
This assessment is useful for evaluating plica retraction
Final treatment opinion [24 months follow-up]
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".
Patient Rehabilitation Monitoring [12 months follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;
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).