NCT04163172

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
81mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Feb 2020Dec 2032

First Submitted

Initial submission to the registry

October 31, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

6.9 years

First QC Date

October 31, 2019

Last Update Submit

October 5, 2023

Conditions

Distal Humerus FractureComminuted FractureIntra-Articular Fractures

Outcome Measures

Primary Outcomes (1)

  • Oxford Elbow Score (OES)

    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.

    2 years after surgery.

Secondary Outcomes (4)

  • Mayo Elbow Performance Score (MEPS)

    3 months after surgery and 1, 2, 5, and 10 years after surgery.

  • Pain severity score (VAS)

    3 months after surgery and 1, 2, 5, and 10 years after surgery.

  • Range of motion

    3 months after surgery and 1, 2, 5, and 10 years after surgery.

  • Patients satisfaction

    3 months after surgery and 1, 2, 5, and 10 years after surgery.

Study Arms (2)

Elbow hemiarthroplasty

ACTIVE COMPARATOR

The Latitude anatomical hemiarthroplasty (WRIGHT -Memphis, Tennessee) for distal humeral fractures.

Procedure: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty

Open reduction and internal fixation

ACTIVE COMPARATOR

Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States) for distal humeral fractures.

Procedure: Surgical treatment of distal humeral fracture with double plating.

Interventions

Surgical treatment of distal humeral fracture with elbow hemiarthroplastyPROCEDURE

Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)

Elbow hemiarthroplasty
Surgical treatment of distal humeral fracture with double plating.PROCEDURE

Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)

Open reduction and internal fixation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Distal humeral fracture AO/OTA type C2 or C3 confirmed by plain radiographs with 2 perpendicular views and CT scan.
  • ASA score 1-3 and physically fit for surgery.
  • Age of 50 years or above.

You may not qualify if:

  • Patients unable to follow the rehabilitation protocol or answer the Danish questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon.
  • Significant elbow osteoarthritis as evaluated by the recruiting surgeon based on plain radiographs and CT scan.
  • Fractures that are older than 6 weeks.
  • Other associated elbow fractures.
  • Pathological fractures or relevant elbow pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte University Hospital

Copenhagen, Denmark

RECRUITING

Related Publications (1)

  • Al-Hamdani A, Rasmussen JV, Holtz K, Olsen BS. Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial. Trials. 2020 Jun 8;21(1):497. doi: 10.1186/s13063-020-04418-8.

    PMID: 32513252DERIVED

MeSH Terms

Conditions

Humeral Fractures, DistalFractures, ComminutedIntra-Articular Fractures

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesHumeral FracturesFractures, Bone

Study Officials

  • Ali Al-Hamdani, MD

    Herlev and Gentofte University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Al-Hamdani, MD

CONTACT

004538673276ali.kuthayer.khalil.al-hamdani@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, shoulder and elbow surgeon.

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 14, 2019

Study Start

February 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2032

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)