Clinical Effect of the Axillary Approach to Glenoid Fractures

Clinical Effect of the Axillary Approach to Acute Anterior Glenoid Fractures

Glenoid fractures result in glenohumeral post-trauma arthritis and instability. Operative treatment is indicated for severe fractures. The traditional deltopectoral approach, which requires detachment of the subscapularis, has many drawbacks, including loss of external rotation and suboptimal fixation. Arthroscopic techniques also cannot allow anatomic reduction and biomechanical stability for large fractures. We describe an alternative approach that enters from the axilla through the interval between the rotator cuff and the inferior glenoid, neck and lateral border of the scapula without detachment of the rotator cuff.

Study Overview

• Status: Recruiting
• Conditions: Fracture; Glenoid
• Intervention / Treatment: Procedure: The axillary approach

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Tian, M.D; Phone Number: +86 13701053505; Email: tiany@bjmu.edu.cn
• Study Contact Backup: Name: Yong Xing; Phone Number: +8618826227164; Email: xingyong@bjmu.edu.cn

Study Locations

• China
  • Beijing, China, 100083
    • Recruiting
    • Peking University Third Hospita
    • Contact: Yun Tian, M.D; Phone Number: +8613701053505; Email: tiany@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Traumatic and closed fractures
• Fracture type conforms to Ideberg Ia classification or AO/OTA F1.1 classification
• Fracture displacement ≥4mm, the area of involvement ≥20%.

Exclusion Criteria:

• Severe multiple trauma
• Pathological fracture
• Unable to tolerate surgical treatment
• The interval between injury and operation was > 2 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; Undergo the axillary approach	Procedure: The axillary approach; The approach enters from the axilla through the interval between the latissimus dorsi and subscapularis to expose the anteroinferior glenoid, neck and lateral border of the scapula with entire rotator cuff sparing and fix the fracture with screws or plates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fracture union	X-rays and CT scans are used to evaluate the bone union	6 months
the Constant and Murley scores	The questionaire evaluates shoulder function in terms of pain (15 points), daily activities (20 points), range of motion (40 points) and muscle strength (25 points) on a scale of 100, with the higher the score, the better the function.	2 years
the DASH(disabilities of the arm，shoulder and hand) scores	Shoulder function was evaluated by patients' subjective feelings about pain, activity, daily life, work and entertainment of the affected limb in the past 1 week. A total of 30 items were evaluated, and the score of each item was 1-5, DASH= (total score-30) /1.2, with the maximum score of 100, the lower the score, the better the function	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	The presence of postoperative complications,including implant failure, osteolysis, and soft-tissue reactions, are determined by symptoms and images.	2 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2019
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (ACTUAL): March 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: IRB00006761-M2019363

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No