Examination of Edema After Arthroscopic Shoulder Surgery

NCT06014203 | Recruiting

• 1 other identifier: Iayas5
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators's aim is to examine trunk and upper extremity edema after arthroscopic rotator cuff repair and/or labrum repair surgeries. During surgery, the shoulder joint capsule is cut and the joint is entered arthroscopically. During this procedure, approximately 3-6 liters of saline fluid is injected into the joint, depending on the duration of the surgery. The given fluid accumulates out of the joint in relation to the duration of the surgery and the amount of fluid given. In this study, the investigators aim is to examine how much the extra-articular fluid collects under the skin of the upper extremity and trunk, and the change in the amount of fluid 24 hours after surgery. Examination of the amount of subcutaneous fluid may help to better understand the postoperative complications such as edema, carpal tunnel syndrome, compartment syndrome, myolysis, and dyspnea. How much edema the joint and surrounding structures are exposed to and its relationship with the duration of surgery can help to clinicians determine the safe discharge time.

Conditions

Edema; Arthroscopy; Shoulder

Keywords

Edema; Shoulder arthroscopy

Outcome Measures

Primary Outcomes (1)

• Edema

  After the MoistureMeterD Compact local edema measuring device is placed perpendicular to the area to be measured, it will be held for 3 seconds and the percent moisture value will be recorded. 3 measurements will be made for each region. The average of the 3 measurements will be used in the statistical analysis.

  3 months

Secondary Outcomes (2)

• Surgery time

  3 months

• Amount of the saline

  3 months

Study Arms (1)

Patients undergoing shoulder arthroscopy surgery

Patients who underwent arthroscopic shoulder surgery by a single surgeon at Gazi Hospital Department of Orthopedics and Traumatology (rotator cuff repair, slap, bankart repair)

Diagnostic Test: Edema measurement

Interventions

Edema measurement DIAGNOSTIC_TEST

Subcutaneous fluid measurements will be made 3 times in total, before the surgery, immediately after the surgery and 24 hours after the surgery. Measurements will be made with the MoistureMeterD Compact local edema measuring device. Points to be measured: 1. Midpoint of the upper trapezius muscle 2. 5 cm distal to anterior acromion 3. 5cm distal to lateral acromion 4. 5cm distal to posterior acromion 5. 3cm medial to the axilla 6. Anterior cubital fossa 7. Carpal tunnel

Patients undergoing shoulder arthroscopy surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for arthroscopic shoulder surgery in Gazi University Hospital, Department of Orthopedics and Traumatology

You may qualify if:

• Arthroscopic shoulder surgery planned
• years old

You may not qualify if:

• Frozen/stiff shoulder
• Metabolic and endocrine diseases
• Dermatological pathologies
• Hyperlaxity

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Ayas IH, Akcan YO, Haspolat M, Tokgoz MA, Keser I, Kanatli U. Subcutaneous Pectoral Edema After Arthroscopic Labral Repair Despite Normal Irrigation Fluid Usage and Surgery Duration. Orthop Surg. 2025 Feb;17(2):624-630. doi: 10.1111/os.14324. Epub 2025 Jan 15.

  PMID: 39814377 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulunay Kanatlı

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

İnci H Ayas

CONTACT

05071740342; inciayass@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: September 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 10, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)