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Clinical Effect of the Axillary Approach to Glenoid Fractures

Primary Purpose

Fracture; Glenoid

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The axillary approach
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture; Glenoid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third HospitaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

Undergo the axillary approach

Outcomes

Primary Outcome Measures

fracture union
X-rays and CT scans are used to evaluate the bone union
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.
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

Secondary Outcome Measures

Complications
The presence of postoperative complications,including implant failure, osteolysis, and soft-tissue reactions, are determined by symptoms and images.

Full Information

First Posted
July 1, 2021
Last Updated
March 14, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05279261
Brief Title
Clinical Effect of the Axillary Approach to Glenoid Fractures
Official Title
Clinical Effect of the Axillary Approach to Acute Anterior Glenoid Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture; Glenoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Undergo the axillary approach
Intervention Type
Procedure
Intervention Name(s)
The axillary approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
fracture union
Description
X-rays and CT scans are used to evaluate the bone union
Time Frame
6 months
Title
the Constant and Murley scores
Description
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.
Time Frame
2 years
Title
the DASH(disabilities of the arm,shoulder and hand) scores
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Complications
Description
The presence of postoperative complications,including implant failure, osteolysis, and soft-tissue reactions, are determined by symptoms and images.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Tian, M.D
Phone
+86 13701053505
Email
tiany@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Xing
Phone
+8618826227164
Email
xingyong@bjmu.edu.cn
Facility Information:
Facility Name
Peking University Third Hospita
City
Beijing
ZIP/Postal Code
100083
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Tian, M.D
Phone
+8613701053505
Email
tiany@bjmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Clinical Effect of the Axillary Approach to Glenoid Fractures

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