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

NCT04943341 | Completed

• 1 other identifier: PLICA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Medial Plica Syndrome

Keywords

medial plica syndrome; medial plica; knee; Pilot study; Triamcinolone Acetonide; injection treatment

Outcome Measures

Primary Outcomes (1)

• KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS

  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 Outcomes (7)

• KOOS (Knee Injury and Osteoarthritis Outcome Score)

  baseline, 1 month, 3 months, 6 and 12 months FU

• VAS (Visual Analogue Scale)

  baseline, 1 month, 3 months, 6 and 12 months FU

• Patient Acceptable Symptom State (PASS)

  baseline, 1 month, 3 months, 6 and 12 months, 24 months FU

• Ultrasound assessment

  baseline, 1 month, 3 months FU

• MRI assessment

  baseline, 6 months FU

Study Arms (1)

Eco-guided Triamcinolone-Acetonide injection

EXPERIMENTAL

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

Procedure: Eco-guided Triamcinolone-Acetonide injection

Interventions

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.

Eco-guided Triamcinolone-Acetonide injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ultrasonographic and/or MRI signs of medial plica pathology;
• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (7)

• Bellary SS, Lynch G, Housman B, Esmaeili E, Gielecki J, Tubbs RS, Loukas M. Medial plica syndrome: a review of the literature. Clin Anat. 2012 May;25(4):423-8. doi: 10.1002/ca.21278.

  PMID: 22331585 BACKGROUND

• Dupont JY. Synovial plicae of the knee. Controversies and review. Clin Sports Med. 1997 Jan;16(1):87-122. doi: 10.1016/s0278-5919(05)70009-0.

  PMID: 9012563 BACKGROUND

• Jee WH, Choe BY, Kim JM, Song HH, Choi KH. The plica syndrome: diagnostic value of MRI with arthroscopic correlation. J Comput Assist Tomogr. 1998 Sep-Oct;22(5):814-8. doi: 10.1097/00004728-199809000-00028.

  PMID: 9754123 BACKGROUND

• Amatuzzi MM, Fazzi A, Varella MH. Pathologic synovial plica of the knee. Results of conservative treatment. Am J Sports Med. 1990 Sep-Oct;18(5):466-9. doi: 10.1177/036354659001800503.

  PMID: 2252085 BACKGROUND

• Rovere GD, Adair DM. Medial synovial shelf plica syndrome. Treatment by intraplical steroid injection. Am J Sports Med. 1985 Nov-Dec;13(6):382-6. doi: 10.1177/036354658501300603.

  PMID: 4073344 BACKGROUND

• Collins NJ, Prinsen CA, Christensen R, Bartels EM, Terwee CB, Roos EM. Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage. 2016 Aug;24(8):1317-29. doi: 10.1016/j.joca.2016.03.010. Epub 2016 Mar 21.

  PMID: 27012756 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

Study Officials

• Luca Andriolo, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 outcomes

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 29, 2021
• Study Start: October 28, 2021
• Primary Completion: September 16, 2024
• Study Completion: September 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)