Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures

Proximal Humeral Fracture Clinical Trial

Official title:

Comparison of Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786639
• Other study ID #: IUC1
• Status: Completed
• Start date: March 12, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: July 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The management of proximal humerus fractures (PHFs) remains a significant challenge in orthopaedics. The acute treatment options for PHFs are numerous and are typically guided by the fracture pattern and functional demands of the patients. The most commonly used methods include non-operative management with a sling or surgical fixation. Although non-surgical treatment is a reasonable treatment option for the majority of humerus fractures, there is an increasing interest in surgical intervention. There are no evidence-based treatment recommendations, thus permitting large local variation in treatment preferences. There are a number of studies in the literature about how outcome measures of the patients after PHFs management change, but these results generally compare functional results before and after treatment. Misra et al. stated that conservatively managed patients with PHFs have more pain and a poorer range of motion than those managed by either fixation or arthroplasty, while cochrane review stated that surgery is not superior to nonsurgical treatment in most proximal humerus fractures. Jayakumar et al. determined that kinesiophobia is one of the strongest predictors of functional limitation and recovery from a PHF is enhanced by overcoming fears of movement or reinjury within a week after injury. There is no clear knowledge regarding how the surgical or conservative management used in the management of PHF affects the early results of assessment parameters. The aim of this study was to compare early results of surgical fixation versus non-operative management outcomes in patients with proximal humerus fractures.

Description:

Voluntary patients who have been diagnosed with proximal humerus fracture and managed by surgical or conservative will be included in the study. Patients with stabilization after proximal humerus fracture with surgical fixation will be considered as the Surgery group, and patients treated with non-surgical treatment with sling immobilization will be considered as the Conservative group. Signed voluntary consent will be obtained from participants. Patients having surgical fixation or nonoperative management will be assessed for kinesiophobia, pain, range of motion, functional status, and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 15, 2023
• Est. primary completion date: May 12, 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Stabilization after proximal humerus fracture with surgical fixation (post-op 3-6 weeks) or non-surgical treatment with sling immobilization (callus formation on radiography).
• Volunteer

Exclusion Criteria:

• Malunion tubercle majus,
• Advanced osteoporosis,
• Avascular necrosis of the humeral head,
• Presence of neurological and rheumatologic disease,
• Recurrent infection and open wound-incision in the region,
• Communication problems

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Locations

Country	Name	City	State
Turkey	Ayse Alpözgen	Küçükçekmece	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinesiophobia	Tampa kinesiophobia scale will be used for determining of kinesiophobia or fear of movement.The Tampa Scale for Kinesiophobia is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The score varies between 17 and high scores indicate an increasing degree of kinesiophobia.	Baseline
Secondary	Shoulder Pain	A Visual Analogue Scale will be used for pain of rest, night and activity. It is a scale measuring the distance (mm) on the 10-cm line between the "no pain" (0) and and " worst pain (10).	Baseline
Secondary	Range of Motion	Shoulder flexion, extension, external and internal rotation will be measured by using digital goniometer. It is a reliable and valid tool for measuring shoulder range of motion in individuals with healthy shoulders. Increasing the degree is considered as an improvement in the range of motion.	Baseline
Secondary	Functional Status	The Disabilities of the Arm, Shoulder and Hand questionnaire will be used for measuring of self-rated upper-extremity disability and symptoms. The scale score ranging is from 0 (no disability) to 100 (most severe disability).	Baseline
Secondary	Quality of Life of the patients	The quality of life will be assessed by using 36-Item Short Form Survey. The survey has eight sub scaled scores; vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Scores range from 0 - 100 and higher scores shows less disability.	Baseline