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临床试验/NCT07228936
NCT07228936招募中不适用

The Role of Pectoralis Minor Muscle Tightness in the Development of Rotator Cuff Tears: A Propensity Score Matched Case-Control Study

Gazi University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年6月18日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Pectoralis minor muscle length difference between case and control groups

研究概览

简要总结

This study investigates whether tightness of a small chest muscle called the pectoralis minor is associated with the development of partial rotator cuff tears in the shoulder. Using a propensity score matched case-control design, the study compares patients with rotator cuff tears (case group, n=45) to patients with intact rotator cuffs (control group, n=45).

Adults aged 18-55 who are evaluated by MRI and/or shoulder arthroscopy at Gazi University Hospital may be invited. The case group includes patients found to have partial rotator cuff tears during arthroscopy. The control group includes patients whose rotator cuff was documented as intact by MRI. Groups are matched 1:1 on age, sex, BMI, and dominant side.

Before surgery, two trained clinician measures shoulder posture and pectoralis minor length using simple external tools (a digital caliper and ruler-like square). For arthroscopy patients, the surgeon records general arthroscopic findings. No extra procedures are added for research.

We expect to include 90 participants total. The primary hypothesis is that pectoralis minor tightness is more prevalent in patients with rotator cuff tears compared to controls. A secondary hypothesis is that tears in patients with pectoralis minor tightness more often partial-thickness bursal side rotator cuff tear. Results may help clinicians understand shoulder mechanics and improve prevention or rehabilitation strategies.

详细描述

Rationale and Objectives Pectoralis minor (PM) tightness alters scapular position (anterior tilt, internal rotation) and may increase subacromial compression. This propensity score matched case-control study evaluates whether PM tightness is associated with the development of partial rotator cuff tears (RCTs).

Design and Setting Single-center, propensity score matched case-control study at a tertiary academic hospital (orthopaedic shoulder service, Gazi University Hospital). Care is not altered by participation. All surgical and imaging procedures are standard of care; research procedures are limited to noninvasive postural/PM length measurements and structured data collection.

Participants Inclusion criteria consisted of patients aged 18-55 years who were scheduled to undergo surgical treatment for a partial-thickness rotator cuff tear (case group) and individuals aged 18-55 years with no evidence of rotator cuff or other shoulder pathology on magnetic resonance imaging (control group). Patients were excluded if they had a history of trauma, thoracic outlet syndrome, systemic inflammatory disease, prior surgery on the affected shoulder, and declined participation in the examination. After application of the eligibility criteria, patients with partial-thickness rotator cuff tears will be matched in a 1:1 ratio with patients without rotator cuff or other shoulder pathology. Matching was performed based on age, sex, body mass index (BMI), and dominant extremity involvement. Covariate balance was assessed using absolute standardized differences, with a predefined threshold of 0.1.

Study Procedures

Preoperative assessments (same-day or pre-op clinic):

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • consisted of patients aged 18-55 years who were scheduled to undergo surgical treatment for a partial-thickness rotator cuff tear (case group) and individuals aged 18-55 years with no evidence of rotator cuff or other shoulder pathology on magnetic resonance imaging (control group). Patients were excluded if they had a history of trauma, thoracic outlet syndrome, systemic inflammatory disease, prior surgery on the affected shoulder, and declined participation in the examination.

排除标准

  • Previous surgery on the same shoulder.
  • Recent traumatic shoulder injury such as fracture or dislocation.
  • Rotator cuff tear due to major trauma.
  • Neck/nerve conditions affecting the shoulder, such as cervical radiculopathy or thoracic outlet syndrome.
  • Systemic inflammatory joint disease, such as rheumatoid arthritis or ankylosing spondylitis.
  • Cognitive or communication problems that would prevent accurate measurements or consent.

研究组 & 干预措施

Rotator Cuff Tear (Case)

Patients who underwent shoulder arthroscopy and were found to have partial rotator cuff tears during surgery. Pectoralis minor length, medial scapular distance, and forward shoulder posture were measured preoperatively. Propensity score matched 1:1 with the control group on age, sex, BMI, and dominant side.

Intact Rotator Cuff (Control)

İndividuals aged 18-55 years with no evidence of rotator cuff or other shoulder pathology on magnetic resonance imaging. Propensity score matched 1:1 with the case group on age, sex, BMI, and dominant side.

结局指标

主要结局

Pectoralis minor muscle length difference between case and control groups

时间窗: Preoperative assessment, Day 0

Comparison of pectoralis minor (PM) muscle length (mm) and pectoralis minor index between patients with partial rotator cuff tears (case group) and patients with intact rotator cuffs (control group). PM length is measured as the linear distance from coracoid tip to rib attachment using a digital caliper. The pectoralis minor index was calculated by dividing the pectoralis minor length by the patient's height and multiplying the result by 100.

次要结局

  • Forward shoulder posture(Preoperative assessment, Day 0)
  • Thoracic Kyphosis (Cobb angle)(Preoperative imaging review, Day 0)
  • Medial Scapular Border Thoracic Distance(Preoperative assessment, Day 0)
  • Scapular index (Coracoid-Sternum/Acromian lateral tip - thoracic spine)(Preoperative assessment, Day 0)
  • Tear initiation site in the case group(Intraoperative, Day 0 (index arthroscopy))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cagatay Delice

STUDY_CHAİR GAZİ UNİVERSİTY

Gazi University

研究点 (1)

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