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).
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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koç University Hospital
Istanbul, Zeytinburnu, 34010
Ata Cem Akbaba, Medical Doctor, +905377397395, atacemakbaba1996@hotmail.com
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.
- Conditions
- Calcific Tendinitis of Shoulder
- 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 group | Role | What 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.
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)
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.
- First posted13 Feb 2026
- Study start2 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Calcific Tendinitis of ShoulderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ata Cem Akbaba, Koç University
- Investigators
- Mehmet S Demirhan, Medical Doctor, Principal investigator, Koc University Hospital
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 19501287Birsel 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 39560675Caliskan 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
- ClinicalTrials.gov ID
- NCT07409818
- Acronym / sponsor ID
- 2025.407.IRB2.190
- Conditions
- Calcific Tendinitis of Shoulder
- Keywords
- calcific tendinitis, shoulder, magnetic resonance imaging, calcific deposit, novel classification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Intratendinous Articular (Ta) | – | Procedure: Debridement, Procedure: Side to side repair, Procedure: Anchor FixationCalcific deposit sits inside the tendon, closer to the articular side |
| Intratendinous Bursal (Tb) | – | Procedure: Debridement, Procedure: Side to side repair, Procedure: Anchor FixationCalcific deposit sits inside the tendon, closer to the bursal side |
| Complete Intratendinous (Tc) | – | Procedure: Debridement, Procedure: Side to side repair, Procedure: Anchor FixationThe calcific deposit is entirely within the tendon and completely encompasses the tendon substance. |
| Extratendinous (E) | – | Other: Conservative non-surgical treatmentCalcific deposit located outside the tendon. |
| Intraosseous (I) | – | Procedure: Debridement, Procedure: Side to side repair, Procedure: Anchor FixationCalcific deposit extending into the bone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Patients who underwent surgical treatment for calcific tendinitis
- Presence of single or multiple calcific deposits within the rotator cuff tendons
Key exclusion criteria (3 listed)
- History of prior ipsilateral shoulder surgery for indications other than calcific tendinitis
- Revision surgery for calcific tendinitis
- Incomplete clinical documentation or unavailable MRI data
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 |
|---|---|---|
| Conservative non-surgical treatmentNon surgical conservative treatment consist of all the treatment modalities e.g. analgesic treatment (NSAIDs, paracetamol...), ice packaging, movement restriction, resting etc. | Other | Extratendinous (E) |
| DebridementDebridement intervention can be described as a surgical intervention, which includes debridement of the calcification deposit. | Procedure or surgery | Complete Intratendinous (Tc), Intraosseous (I), Intratendinous Articular (Ta), Intratendinous Bursal (Tb) |
| Side to side repairAfter 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. | Procedure or surgery | Complete Intratendinous (Tc), Intraosseous (I), Intratendinous Articular (Ta), Intratendinous Bursal (Tb) |
| Anchor FixationAnchor 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. | Procedure or surgery | Complete Intratendinous (Tc), Intraosseous (I), Intratendinous Articular (Ta), Intratendinous Bursal (Tb) |
Primary outcome
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
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.
1 secondary outcome
Change from Baseline in Subjective Shoulder Value (SSV) at 12 Months
Time frame: From preoperative assessment (baseline) to 12 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 19501287Seyahi 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.
- Results publication: PubMed 39560675Birsel 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.
- Results publication: PubMed 35044474Caliskan 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.
- Individual participant dataSharing planned: 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.
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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.
Mehmet S Demirhan, Medical Doctor principal investigator
Koc University Hospital
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 6 Nov 2026.