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Completed

NCT Number: NCT04943341

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Eco-guided Triamcinolone-Acetonide injection

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. 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".

  4. Ultrasound assessment

    Time frame: baseline, 1 month, 3 months FU

    This examination is useful to evaluate the evolution of plica thickness;

  5. MRI assessment

    Time frame: baseline, 6 months FU

    This assessment is useful for evaluating plica retraction

  6. 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".

  7. 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jun 29, 2021
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.