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

Not Applicable

Recruiting

• Conditions: Medial Plica Syndrome
• Interventions: Procedure: Eco-guided Triamcinolone-Acetonide injection

• Registration Number: NCT04943341
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

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 Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-29
• Study Start: 2021-10-28
• Primary Completion: 2022-05-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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;

11. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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.
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
Ultrasound assessment	baseline, 1 month, 3 months FU	This examination is useful to evaluate the evolution of plica thickness;
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".

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy