Clinical trial NCT04943341: Evaluation of the Triamcinolone -Acetonide Therapy for the Treatment of the Medial Plica Syndrome
Official title: Eco-guided Treatment With Triamcinolone-Acetonide in the Treatment of Medial Plica Syndrome - A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medial Plica Syndrome
Keywords: medial plica syndrome
medial plica
knee
Pilot study
Triamcinolone Acetonide
injection treatment
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 outcomes
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS
timeFrame: 6 months FU
Secondary outcomes:
measure: KOOS (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: baseline, 1 month, 3 months, 6 and 12 months FU
measure: VAS (Visual Analogue Scale)
timeFrame: baseline, 1 month, 3 months, 6 and 12 months FU
measure: Patient Acceptable Symptom State (PASS)
timeFrame: baseline, 1 month, 3 months, 6 and 12 months, 24 months FU
measure: Ultrasound assessment
timeFrame: baseline, 1 month, 3 months FU
measure: MRI assessment
timeFrame: baseline, 6 months FU
measure: Final treatment opinion
timeFrame: 24 months follow-up
measure: Patient Rehabilitation Monitoring
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Luca Andriolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.