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

November 17, 2025 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS
Time Frame: 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.
6 months FU

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Luca Andriolo, MD, Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2021

Primary Completion (Actual)

September 16, 2024

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLICA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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