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Calcific Tendinitis of ShoulderNCT07409818

A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies

An observational study of Calcific Tendinitis of Shoulder, run by Koç University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Calcific tendinitis of the shoulder is among the frequently encountered shoulder problems. Conservative treatment is often preferred for its management. Persistent pain, impingement symptoms due to large calcific deposits, and extension into the bone are indications for surgical intervention. Read more about this study

Who is it for?
Any age
Conditions the study is for
Calcific Tendinitis of Shoulder
What is being tested?
Conservative non-surgical treatment, Debridement and Side to side repair
Type of treatment
Surgery or procedure
How many people
400 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Oct 2025to 2 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study popuation consists of individuals who were followed for calcific tendinitis and received conservative or surgical treatment by the physicians of our clinic at American Hospital and Koç University Hospital since 2004.

Who may be able to join

  • Patients who underwent surgical treatment for calcific tendinitis
  • Presence of single or multiple calcific deposits within the rotator cuff tendons

Who cannot join

  • History of prior ipsilateral shoulder surgery for indications other than calcific tendinitis
  • Revision surgery for calcific tendinitis
  • Incomplete clinical documentation or unavailable MRI data

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ata Cem Akbaba, Medical Doctor contact

+905377397395

atacemakbaba1996@hotmail.com

İlker Eren, Medical Doctor contact

+905333174047

ilker.eren@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Koç University Hospital

    Istanbul, Zeytinburnu, 34010

    Ata Cem Akbaba, Medical Doctor, +905377397395, atacemakbaba1996@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Calcific tendinitis of the shoulder is among the frequently encountered shoulder problems. Conservative treatment is often preferred for its management. Persistent pain, impingement symptoms due to large calcific deposits, and extension into the bone are indications for surgical intervention.

Although many classification methods for calcific tendinitis have been defined in the literature, none of them is directly related to prognosis, treatment options, or surgical management.

Read more

The aim of this study is to create a new, easy-to-apply, practical, and treatment-related classification system for calcific tendinitis based on the localization of the deposits on MRI.

Furthermore, the aim is to compile the current patient cohort according to this new classification and examine the relationship between the treatment applied and the deposit localization in the proposed classification.

Read the detailed description

Introduction

Calcific tendinopathy (calcific tendinitis) associated with calcific deposits in the shoulder is a common disorder of the rotator cuff tendons. It accounts for up to 7% of all painful shoulders, with the highest prevalence recorded in the fourth and sixth decades. Although the chemical composition of the deposits has been extensively studied across different stages of the disease, the pathogenesis and the factors inducing deposit resorption remain largely unclear. Despite the self-limiting nature of calcific tendinitis, surgical intervention may be required in persistent cases. Surgical treatment primarily involves debridement of the calcific deposit and tendon repair if cuff integrity is compromised. Based on current understanding, calcific tendinitis can be regarded as a form of tendinopathy within the spectrum of rotator cuff tendon disorders.

To date, numerous classification systems have been defined in the literature to characterize calcific deposits in the shoulder. These classifications are based on pathogenesis (Uhthoff-Loehr Classification), plain radiographic imaging(Gärtner-Hayer Classification), and ultrasound imaging (Chiou and Scofienza Classifications). However, none of these systems are directly related to clinical practice or correlate with treatment modalities.

The study aims to establish a novel classification system, based on MRI findings, that is easy to understand and apply, and directly consistent with management options (surgical/conservative). In this study, the aim is to organize the calcific tendinitis patients the investigators have followed according to the system that is recently defined and to evaluate the concordance between the applied treatment modalities and the localization determined by the novel classification.

Materials and Methods

MRI scans, treatment protocols, and operative notes (for those who underwent surgery) of all calcific tendinitis patients followed at the American Hospital and Koç University Hospital since 2004 will be reviewed. Patients will be divided into five groups in the new classification based on the localization of the calcific deposit on MRI. These groups, determined by the location of the calcific deposit, are defined as:

Extratendinous group (E): Calcific deposit located outside the tendon. Intratendinous Articular group (Ta): Calcific deposit located within the tendon, closer to the articular (joint) side.

Intratendinous Bursal group (Tb): Calcific deposit located within the tendon, closer to the bursal side.

Complete Intratendinous group (Tc): Calcific deposit completely encompassing the inside of the tendon.

Intraosseous group (I): Calcific deposit extending into the bone.

To select patients, the MRI scans of all calcific tendinitis cases who presented to and were followed at VKV American Hospital and Koç University Hospital between 2004 and 2025 will be reviewed and grouped according to the aforementioned classification. The operative reports of the patients who were operated on will be examined to determine the surgical procedure performed, and the hospital records of the non-operative patients will be reviewed to determine the conservative treatment methods applied. Patients whose MRI imaging and clinical records are inaccessible or who have conditions precluding clinical evaluation will be excluded from the study. All included patients will be compiled according to the specified classification system. The treatment modalities applied to the patients will be included in the data set, and the relationship between the classification groups and the applied treatment method will be evaluated.

Being tested
Conservative non-surgical treatment, Debridement, Side to side repair, Anchor Fixation
Keywords
calcific tendinitis, shoulder, magnetic resonance imaging, calcific deposit, novel classification
Medical subject headings
Rotator Cuff Tear Arthropathy

What participants receive

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

  • Conservative non-surgical treatmentOther

    Non surgical conservative treatment consist of all the treatment modalities e.g. analgesic treatment (NSAIDs, paracetamol...), ice packaging, movement restriction, resting etc.

  • DebridementProcedure or surgery

    Debridement intervention can be described as a surgical intervention, which includes debridement of the calcification deposit.

  • Side to side repairProcedure or surgery

    After the surgical debridement of the deposit, sometimes there is a rotator cuff defect. Side to side repair group consist of the cases when the defect is repaired side to side primarily.

  • Anchor FixationProcedure or surgery

    Anchor fixation group consist of the cases when the rotator cuff defect cannot be repaired side to side, and the surgeon managed the defect by fixating it to the bone with an anchor.

Study groups in NCT07409818
Study groupRoleWhat they receive
Intratendinous Articular (Ta)Calcific deposit sits inside the tendon, closer to the articular side
Receives: Procedure: Debridement; Procedure: Side to side repair; Procedure: Anchor Fixation
Intratendinous Bursal (Tb)Calcific deposit sits inside the tendon, closer to the bursal side
Receives: Procedure: Debridement; Procedure: Side to side repair; Procedure: Anchor Fixation
Complete Intratendinous (Tc)The calcific deposit is entirely within the tendon and completely encompasses the tendon substance.
Receives: Procedure: Debridement; Procedure: Side to side repair; Procedure: Anchor Fixation
Extratendinous (E)Calcific deposit located outside the tendon.
Receives: Other: Conservative non-surgical treatment
Intraosseous (I)Calcific deposit extending into the bone.
Receives: Procedure: Debridement; Procedure: Side to side repair; Procedure: Anchor Fixation

What is being measured

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

  1. Change from Baseline in American Shoulder and Elbow Surgeons (ASES) Score at 12 Months

    The ASES score is a standardized shoulder assessment form. It consists of a patient self-evaluation section (visual analog scale for pain and instability) and a daily function assessment section. The score ranges from 0 to 100, where 0 indicates the worst possible outcome and 100 indicates the best possible outcome.

    Measured: From preoperative assessment (baseline) to 12 months post-operation

Secondary outcomes (1)
  1. Change from Baseline in Subjective Shoulder Value (SSV) at 12 Months

    The Subjective Shoulder Value (SSV) is a patient-reported outcome measure where the patient assesses the value of their shoulder expressed as a percentage of an entirely normal shoulder. The scale ranges from 0% to 100%, where higher percentages indicate better shoulder function.

    Measured: From preoperative assessment (baseline) to 12 months post-operation

Timeline

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

  1. First posted13 Feb 2026
  2. Study start2 Oct 2025
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion2 Oct 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07409818
Sponsor's protocol ID
2025.407.IRB2.190
Status last verified
Feb 2026
First submitted
20 Jan 2026
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Given the sensitive nature of the patient-specific details, our research group is unwilling to provide this information in order to uphold the principles of patient confidentiality.

Publications

  • Seyahi A, Demirhan M. Arthroscopic removal of intraosseous and intratendinous deposits in calcifying tendinitis of the rotator cuff. Arthroscopy. 2009 Jun;25(6):590-6. doi: 10.1016/j.arthro.2008.12.024.

    PubMed 19501287
  • Birsel O, Caliskan E, Eren I, Yuruk B, Ozben H, Demirhan M. The impact of acromial morphology on the localization and size of calcific tendonitis in the rotator cuff. Acta Orthop Traumatol Turc. 2024 Nov 8;58(5):263-268. doi: 10.5152/j.aott.2024.24035.

    PubMed 39560675
  • Caliskan E, Eren I, Aslan L, Koyuncu O, Seyahi A, Demirhan M. Intraosseous calcific tendinitis of the rotator cuff yields similar outcomes to those of intratendinous lesions despite worse preoperative scores. Knee Surg Sports Traumatol Arthrosc. 2022 Jul;30(7):2485-2491. doi: 10.1007/s00167-022-06870-2. Epub 2022 Jan 19.

    PubMed 35044474

Questions about this trial

What is this clinical trial studying?

An observational study of Calcific Tendinitis of Shoulder, run by Koç University at 1 site in Turkey (Türkiye).

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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Ata Cem Akbaba, Medical Doctor (+905377397395, atacemakbaba1996@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in American Shoulder and Elbow Surgeons (ASES) Score at 12 Months (time frame: From preoperative assessment (baseline) to 12 months post-operation). 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 NCT07409818, which also lists 3 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 13 Feb 2026.

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