Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:29 AM
Study NCT ID:
NCT07409818
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
Sponsor:
Koç University
Organization:
Study Overview
Official Title:
A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: