NCT07409818

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2025Oct 2026

Study Start

First participant enrolled

October 2, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

January 20, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

calcific tendinitisshouldermagnetic resonance imagingcalcific depositnovel classification

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Change from Baseline in Subjective Shoulder Value (SSV) at 12 Months

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

Study Arms (5)

Intratendinous Articular (Ta)

Calcific deposit sits inside the tendon, closer to the articular side

Procedure: DebridementProcedure: Side to side repairProcedure: Anchor Fixation

Intratendinous Bursal (Tb)

Calcific deposit sits inside the tendon, closer to the bursal side

Procedure: DebridementProcedure: Side to side repairProcedure: Anchor Fixation

Complete Intratendinous (Tc)

The calcific deposit is entirely within the tendon and completely encompasses the tendon substance.

Procedure: DebridementProcedure: Side to side repairProcedure: Anchor Fixation

Extratendinous (E)

Calcific deposit located outside the tendon.

Other: Conservative non-surgical treatment

Intraosseous (I)

Calcific deposit extending into the bone.

Procedure: DebridementProcedure: Side to side repairProcedure: Anchor Fixation

Interventions

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

Extratendinous (E)
DebridementPROCEDURE

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

Complete Intratendinous (Tc)Intraosseous (I)Intratendinous Articular (Ta)Intratendinous Bursal (Tb)

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.

Complete Intratendinous (Tc)Intraosseous (I)Intratendinous Articular (Ta)Intratendinous Bursal (Tb)

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.

Complete Intratendinous (Tc)Intraosseous (I)Intratendinous Articular (Ta)Intratendinous Bursal (Tb)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Interventions

Debridement

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Mehmet S Demirhan, Medical Doctor

    Koç University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ata Cem Akbaba, Medical Doctor

CONTACT

İlker Eren, Medical Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Medical Doctor

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 13, 2026

Study Start

October 2, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 2, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations