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NCT04622852 Clinical Trial

Pegs for Osteofixation of Proximal Humeral Fractures

Proximal Humeral Fracture Clinical Trial

Official title:
Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04622852
Other study ID # 2017/681
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date August 1, 2021

Study information
Verified date September 2021
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)

Description:

From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events: 1. Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and 2. Avascular head necrosis / sinking / need of re-surgery 3. Clinical PROMS

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date August 1, 2021
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 55 Years to 90 Years
Eligibility Inclusion Criterion: - Acute proximal humeral fracture - AO/OTA type 11-B2 or 11C2 Exclusion Criteria: - Not eligible to surgical treatment - Non-compliant - Former shoulder fracture or symptomatic shoulder illness - Drug abuser

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Open reduction internal fixation (ORIF) with an angular stable plate
Operative treatment of proximal humeral fracture

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peg penetration into glenohumeral joint Radiographic or CT verified peg penetration 12 months
Primary Screw penetration into glenohumeral joint Radiographic or CT verified screw penetration 12 months
Secondary Humeral head deformation Avascular head necrosis or Sinking 12 months
Secondary Shoulder function Constant-Murley score 12 months
Secondary Self reported shoulder function Oxford scoulder score 12 months
Secondary Quality of life Generic 15D score 12 months
See also
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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
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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
Completed NCT04786639 - Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
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
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