Reliability of the Subacromial Distance Measurements With Standard Radiographic Imaging

Rotator Cuff Tears Clinical Trial

Official title:

Prospective Evaluation of the Reliability and Re-applicability of Subacromial Distance Measurement With Standard Radiographic Imaging Compared to Ultrasound Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759027
• Other study ID #: E-83045809-604.01.02-1214
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with complaints of shoulder pain or limitation of motion, who admitted to outpatient orthopaedic clinic will be analyzed. It was planned to measure the subacromial distance using standardized both shoulder ap, true ap and outlet radiographs, and ultrasound to be performed for shoulder circumference soft tissue and muscle-tendon evaluation. The measurement made by the physical therapy and rehabilitation specialist with ultrasound will be considered to be accurate, and it was planned to evaluate the reliability of the graphy measurements by comparing this measurement with the measurements in the graphs. In addition, it was planned to evaluate the intra-observer and inter-observer compliance by re-measuring the subacromial distance on the radiograph by orthopedic doctors of three different seniority levels with an interval of one month.

Description:

Rotator cuff injuries are the most common injury to the shoulder girdle. Patients present to the clinic with shoulder compression at an early age and with tears in older ages. Nearly 50% of the population can be torn in advanced ages. Repetitive trauma caused by overuse is blamed for rotator cuff tears. The narrowing of the subacromial distance causes compression in the anterior, tears and enlargement of the tears by extrinsic mechanism. In addition, the surgery to be performed according to the subacromial distance and the benefit to the patient from this surgery can be predicted. In studies conducted in normal population, subacromial distance was reported to be between 6-12 mm, measurements made under 6-7 mm were evaluated as pathologically and were defined as tears that would not benefit from repair.

The reliability of this measurement, which guides the diagnosis and treatment, is important. The diagnosis of these diseases is made by imaging methods following the physical examination and then the decision of the appropriate treatment method is made. It is known that conventional radiographs constitute the first step of evaluation as a standard in almost all patients in orthopedic practice. Magnetic resonance imaging and ultrasound are often preferred for shoulder, shoulder circumference pathology and injuries, in relation to the examination findings after direct radiography at the diagnosis and examination stage. Drawing graphs on both shoulders from these images to provide comparative evaluation provides more detailed information in evaluation. The subacromial distance or acromiohumeral distance used in the evaluation of rotator cuff pathologies was defined as the shortest distance between the sclerotic inferior border of the acromion and the humeral head. The measurement of this distance can be made with direct graphy, mri, ct, and ultrasound. In the only systematic review on this subject, it was emphasized that this measurement can be made with ultrasound as the most reliable, and the evaluations made by direct radiography are worthless. In these inferences, the poor methodology of the studies made using direct graphy measurement was shown as the reason. Many studies have been carried out by standardizing the imaging, its importance has been proven by the inconsistent results of the study with non-standardized graphs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• shoulder pain ( acute traumatic or non-traumatic chronic)

Exclusion Criteria:

• end stage glenohumeral joint arthrosis

• adhesive capsulitis

• fractures

• previous shoulder surgery

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Impingement Syndrome
• Subacromial Impingement

Intervention

Other:
• subacromial distance measurement
distance between acromion and humerus

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Göker Utku deger

Country where clinical trial is conducted

Turkey, 

References & Publications (19)

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van de Sande MA, Rozing PM. Proximal migration can be measured accurately on standardized anteroposterior shoulder radiographs. Clin Orthop Relat Res. 2006 Feb;443:260-5. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RELIABILITY OF DIRECT RADIOGRAPHY IMAGING	The investigators will compare the results of subacromial distance measure on X-ray and ultrasound. Ultrasound measures were accepted as gold standart method.	within 2 weeks after first evaluation
Secondary	REPRODUCIBLITY	if X-ray measurements will correlate with ultrasound, the investigators will evaluate intraobserver and interobserver measurement differences	1 month apart measurements will be evaluate