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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKoç University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who underwent surgical treatment for calcific tendinitis

Presence of single or multiple calcific deposits within the rotator cuff tendons

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Conservative non-surgical treatment

    Other intervention

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

  • Debridement

    Procedure/Surgery

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

  • Side to side repair

    Procedure/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 Fixation

    Procedure/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.

Treatment groups

400 Participants
are divided into 5 treatment groups
Group A: Intratendinous Articular (Ta)3 interventions
Group B: Intratendinous Bursal (Tb)3 interventions
Group C: Complete Intratendinous (Tc)3 interventions
Group D: Extratendinous (E)1 intervention
Group E: Intraosseous (I)3 interventions

Trial outcomes

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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

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