Surgical Fixation & Non-Operative Management Outcomes in Proximal Humerus

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04786639
Study type	Observational
Source	Istanbul University - Cerrahpasa (IUC)
Contact
Status	Completed
Phase
Start date	March 12, 2021
Completion date	May 15, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04762667` - Individual Preoperative Planning for RSA	N/A
Active, not recruiting	`NCT03531463` - The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly	N/A
Terminated	`NCT03711591` - Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device
Completed	`NCT03339570` - Orthopaedic Treatment Proximal Humeral Fractures
Completed	`NCT03919422` - Paravertebral Block for Proximal Humeral Fracture Surgery	N/A
Completed	`NCT01984112` - Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts	N/A
Completed	`NCT00863473` - Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment	Phase 2
Recruiting	`NCT04543682` - A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture	Phase 1/Phase 2
Completed	`NCT05215613` - PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
Recruiting	`NCT04748016` - 3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair	N/A
Active, not recruiting	`NCT04623346` - Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic
Recruiting	`NCT05437822` - Tranexamic Acid in Proximal Humeral Fractures	Phase 4
Terminated	`NCT03567954` - The Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Proximal Humerus Fracture Patients
Recruiting	`NCT03626038` - Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System	N/A
Not yet recruiting	`NCT05960435` - Proprioceptive Neuromuscular Facilitation Techniques in Proximal Humerus Fractures	N/A
Recruiting	`NCT03243409` - Perioperative Complications in Reversed Shoulder Arthroplasties	N/A
Completed	`NCT04622852` - Pegs for Osteofixation of Proximal Humeral Fractures
Terminated	`NCT02073695` - Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace	N/A
Recruiting	`NCT04523415` - Researches About Proximal Humerus Fractures
Active, not recruiting	`NCT03097406` - Functional Outcome and Complications After Global Unite ® Prostheses

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms