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

Primary Purpose

Medial Plica Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Eco-guided Triamcinolone-Acetonide injection

About this trial

This is an interventional treatment trial for Medial Plica Syndrome focused on measuring medial plica syndrome, medial plica, knee, Pilot study, Triamcinolone Acetonide, injection treatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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;

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).

Sites / Locations

Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eco-guided Triamcinolone-Acetonide injection

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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

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".

Ultrasound assessment

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

MRI assessment

This assessment is useful for evaluating plica retraction

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".

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.

Full Information

NCT ID

NCT04943341

First Posted

May 17, 2021

Last Updated

September 12, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT04943341

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 28, 2021 (Actual)

Primary Completion Date

May 19, 2022 (Actual)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Medial Plica Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eco-guided Triamcinolone-Acetonide injection

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Eco-guided Triamcinolone-Acetonide injection

Intervention Description

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 Outcome Measure Information:

Title

KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS

Description

Time Frame

6 months FU

Secondary Outcome Measure Information:

Title

KOOS (Knee Injury and Osteoarthritis Outcome Score)

Description

Time Frame

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

Title

VAS (Visual Analogue Scale)

Description

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

Time Frame

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

Title

Patient Acceptable Symptom State (PASS)

Description

Time Frame

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

Title

Ultrasound assessment

Description

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

Time Frame

baseline, 1 month, 3 months FU

Title

MRI assessment

Description

This assessment is useful for evaluating plica retraction

Time Frame

baseline, 6 months FU

Title

Final treatment opinion

Description

Time Frame

24 months follow-up

Title

Patient Rehabilitation Monitoring

Description

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.

Time Frame

12 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Roberta Licciardi, Msc

Phone

0516366567

roberta.licciardi@ior.it

First Name & Middle Initial & Last Name or Official Title & Degree

Luca Andriolo, MD

luca.andriolo@ior.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luca Andriolo, MD

Organizational Affiliation

Istituto Ortopedico Rizzoli

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Ortopedico Rizzoli

City

Bologna

ZIP/Postal Code

40136

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luca Andriolo, MD

Phone

6366567

luca.andriolo@ior.it

First Name & Middle Initial & Last Name & Degree

Roberta Licciardi, MSc

Phone

6366567

roberta.licciardi@ior.it

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22331585

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.

Results Reference

background

PubMed Identifier

9012563

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.

Results Reference

background

PubMed Identifier

9754123

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.

Results Reference

background

PubMed Identifier

2252085

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.

Results Reference

background

PubMed Identifier

4073344

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.

Results Reference

background

PubMed Identifier

27012756

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.

Results Reference

background

PubMed Identifier

30211382

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.

Results Reference

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

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