Medial Plica SyndromeNCT04943341

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

A study testing Eco-guided Triamcinolone-Acetonide injection in people with Medial Plica Syndrome, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Medial Plica Syndrome
What is being tested?: Eco-guided Triamcinolone-Acetonide injection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteItaly
Study dates: 28 Oct 2021to 30 Sep 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

Who cannot join

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;

Show all 11Show fewer

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).

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Ortopedico Rizzoli
Bologna, 40136

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions: Medial Plica Syndrome
Being tested: Eco-guided Triamcinolone-Acetonide injection
Keywords: medial plica syndrome, medial plica, knee, Pilot study, Triamcinolone Acetonide, injection treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eco-guided Triamcinolone-Acetonide injectionProcedure or surgery
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.

Study groups in NCT04943341
Study group	Role	What they receive
Eco-guided Triamcinolone-Acetonide injection	Experimental	Patients affected by medial plica syndrome will be treated with an eco-guided injection of Triamcinolone-Acetonide. Receives: Procedure: Eco-guided Triamcinolone-Acetonide injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months FU

Secondary outcomes (7)

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).
Measured: baseline, 1 month, 3 months, 6 and 12 months FU
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
Measured: baseline, 1 month, 3 months, 6 and 12 months FU
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".
Measured: baseline, 1 month, 3 months, 6 and 12 months, 24 months FU
Ultrasound assessment
This examination is useful to evaluate the evolution of plica thickness;
Measured: baseline, 1 month, 3 months FU
MRI assessment
This assessment is useful for evaluating plica retraction
Measured: baseline, 6 months FU
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".
Measured: 24 months follow-up
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.
Measured: 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202130 Sep 2025

First posted29 Jun 2021
Study start28 Oct 2021
Primary completion16 Sep 2024
Study completion30 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Medial Plica SyndromeStudies of the same condition, open and under way.
More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04943341
Sponsor's protocol ID: PLICA
Status last verified: Nov 2025
First submitted: 17 May 2021
Last updated: 18 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22331585
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.
PubMed 9012563
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.
PubMed 9754123
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.
PubMed 2252085
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.
PubMed 4073344
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.
PubMed 27012756
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.
PubMed 30211382

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Eco-guided Treatment With Triamcinolone-Acetonide in the Treatment of Medial Plica Syndrome - A Pilot Study
ClinicalTrials.gov ID: NCT04943341
Acronym / sponsor ID: PLICA
Conditions: Medial Plica Syndrome
Keywords: medial plica syndrome, medial plica, knee, Pilot study, Triamcinolone Acetonide, injection treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Istituto Ortopedico RizzoliUniversity, hospital or other
Study start: 28 Oct 2021 (actual)
Primary completion: 16 Sep 2024 (actual)
Study completion: 30 Sep 2025 (actual)
First posted: 29 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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

Arm	Type	Receives
Eco-guided Triamcinolone-Acetonide injection	Experimental	Procedure: Eco-guided Triamcinolone-Acetonide injectionPatients affected by medial plica syndrome will be treated with an eco-guided injection of Triamcinolone-Acetonide.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Eco-guided Triamcinolone-Acetonide injectionThe 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.	Procedure or surgery	Eco-guided Triamcinolone-Acetonide injection

Primary outcome

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.

7 secondary outcomes

KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: baseline, 1 month, 3 months, 6 and 12 months FU
VAS (Visual Analogue Scale)
Time frame: baseline, 1 month, 3 months, 6 and 12 months FU
Patient Acceptable Symptom State (PASS)
Time frame: baseline, 1 month, 3 months, 6 and 12 months, 24 months FU
Ultrasound assessment
Time frame: baseline, 1 month, 3 months FU
MRI assessment
Time frame: baseline, 6 months FU
Final treatment opinion
Time frame: 24 months follow-up
Patient Rehabilitation Monitoring
Time frame: 12 months follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Background: PubMed 22331585Bellary 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.
Background: PubMed 9012563Dupont 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.
Background: PubMed 9754123Jee 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.
Background: PubMed 2252085Amatuzzi 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.
Background: PubMed 4073344Rovere 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.
Background: PubMed 27012756Collins 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.
Background: PubMed 30211382Delgado 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luca Andriolo, MD principal investigator

Istituto Ortopedico Rizzoli

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Eco-guided Triamcinolone-Acetonide injection in people with Medial Plica Syndrome, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS (time frame: 6 months FU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04943341, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.