Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Denmark / NCT04163172
Recruiting Not applicable

Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

NCT04163172 · tracked via the Priya Life Science Denmark tracker
Sponsor
Herlev and Gentofte Hospital
Phase
Not applicable
Started
2020-02-01
Last updated
2023-10-06

Condition(s) studied

Distal Humerus FractureComminuted FractureIntra-Articular Fractures

Investigational drug(s) / intervention(s)

Surgical treatment of distal humeral fracture with elbow hemiarthroplastySurgical treatment of distal humeral fracture with double plating.

Surgical treatment of distal humeral fracture with elbow hemiarthroplasty: Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)

Surgical treatment of distal humeral fracture with double plating.: Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)

Study summary

This is a randomized control trial comparing the outcome of ORIF (open reduction and internal fixation) with EHA (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 years or above.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Distal humeral fracture AO/OTA type C2 or C3 confirmed by plain radiographs with 2 perpendicular views and CT scan. 2. ASA score 1-3 and physically fit for surgery. 3. Age of 50 years or above. Exclusion Criteria: 1. Patients unable to follow the rehabilitation protocol or answer the Danish questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon. 2. Significant elbow osteoarthritis as evaluated by the recruiting surgeon based on plain radiographs and CT scan. 3. Fractures that are older than 6 weeks. 4. Other associated elbow fractures. 5. Pathological fractures or relevant elbow pathology.

Primary outcome measure(s)

  • Oxford Elbow Score (OES) — 2 years after surgery.
    The OES is a 12-item patient-administrated questionnaire that measures the quality of life in patients with elbow disorder. There are three unidimensional domains: Elbow function, pain, and social-psychological status. Each question is answered on a 5-point scale with each question contributing equally to the total score.Thus, the total score ranges from 12-60, with 60 being the worst. For ease of presentation the score is converted to a scale from 0-48 with 48 being the best. The outcome can be interpreted based on a 48-point scale: 0 - 19 - poor; 20-29 - fair; 30-39 - good; and 40-48 - excellent. The Danish version which will be used in this study, has been translated and cultural adapted according to the guidelines by Guillemin, Bombardier and Beaton.

Trial sites (1)

FacilityCityRegionStatus
Herlev and Gentofte University Hospital Copenhagen Denmark Recruiting

More Herlev and Gentofte Hospital trials in Denmark

The COLchicine and Atrial FIBrillation Trial Recruiting
Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System Recruiting
HIDRAdenitis Suppurativa and HEART Disease Active, not recruiting
A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record Recruiting
HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04163172 on ClinicalTrials.gov ↗ ← All trials in Denmark