跳至主要内容
临床试验/NCT07409818
NCT07409818招募中不适用

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

Koç University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年10月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Change from Baseline in American Shoulder and Elbow Surgeons (ASES) Score at 12 Months

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Intratendinous Bursal (Tb)

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

干预措施: Anchor Fixation (Procedure)

Intratendinous Articular (Ta)

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

干预措施: Debridement (Procedure)

Intratendinous Articular (Ta)

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

干预措施: Side to side repair (Procedure)

Intratendinous Articular (Ta)

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

干预措施: Anchor Fixation (Procedure)

Intratendinous Bursal (Tb)

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

干预措施: Debridement (Procedure)

Intratendinous Bursal (Tb)

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

干预措施: Side to side repair (Procedure)

Complete Intratendinous (Tc)

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

干预措施: Debridement (Procedure)

Complete Intratendinous (Tc)

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

干预措施: Side to side repair (Procedure)

Complete Intratendinous (Tc)

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

干预措施: Anchor Fixation (Procedure)

Extratendinous (E)

Calcific deposit located outside the tendon.

干预措施: Conservative non-surgical treatment (Other)

Intraosseous (I)

Calcific deposit extending into the bone.

干预措施: Debridement (Procedure)

Intraosseous (I)

Calcific deposit extending into the bone.

干预措施: Side to side repair (Procedure)

Intraosseous (I)

Calcific deposit extending into the bone.

干预措施: Anchor Fixation (Procedure)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Change from Baseline in Subjective Shoulder Value (SSV) at 12 Months(From preoperative assessment (baseline) to 12 months post-operation)

研究者

发起方
Koç University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ata Cem Akbaba

Research Assistant Medical Doctor

Koç University

研究点 (1)

Loading locations...

相似试验