Clinical trial NCT04786639: Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
Official title: Comparison of Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fracture
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proximal humerus fracture who come to the orthopedic clinic.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Kinesiophobia
timeFrame: Baseline
Secondary outcomes:
measure: Shoulder Pain
timeFrame: Baseline
measure: Range of Motion
timeFrame: Baseline
measure: Functional Status
timeFrame: Baseline
measure: Quality of Life of the patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Küçükçekmece
country: Turkey
facility: Ayşe Alpözgen
state: İstanbul
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayse Zengin Alpozgen, PhD
role: PRINCIPAL_INVESTIGATOR
References: