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

NCT04786639 | Completed

• 1 other identifier: IUC1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Proximal Humeral Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Shoulder Pain

  Baseline

• Range of Motion

  Baseline

• Functional Status

  Baseline

• Quality of Life of the patients

  Baseline

Study Arms (2)

Surgical Fixation Group

Open reduction with deltopectoral incision and humeral osteosynthesis with anatomic plates and screws will be performed for surgical fixation.

Non-Operative Group

Non-surgical treatment will be performed with sling immobilization.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with proximal humerus fracture who come to the orthopedic clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Ayşe Alpözgen

Küçükçekmece, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Ayse Zengin Alpozgen, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: March 12, 2021
• Primary Completion: May 12, 2023
• Study Completion: May 15, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

TU (1)