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

Medial Plica Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943341
• Other study ID #: PLICA
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Roberta Licciardi, Msc
• Phone: 0516366567
• Email: roberta.licciardi[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Medial Plica Syndrome
• Syndrome
• Synovitis

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	KOOS (Knee Injury and Osteoarthritis Outcome Score)	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
Secondary	VAS (Visual Analogue Scale)	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
Secondary	Patient Acceptable Symptom State (PASS)	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
Secondary	Ultrasound assessment	This examination is useful to evaluate the evolution of plica thickness;	baseline, 1 month, 3 months FU
Secondary	MRI assessment	This assessment is useful for evaluating plica retraction	baseline, 6 months FU
Secondary	Final treatment opinion	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
Secondary	Patient Rehabilitation Monitoring	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