Clinical trial NCT04163172: Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures
Official title: Elbow Hemiarthroplasty Versus Open Reduction and Internal Fixation for AO/OTA Type C2 and C3 Fractures of Distal Humerus in Patients Aged 50 Years or Above; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Humerus Fracture
Comminuted Fracture
Intra-Articular Fractures
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Intraarticular distal humeral fractures AO/OTA type C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results are varying, and sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semiconstrained TEA. There are no studies comparing the results of EHA to that of TEA or ORIF, but case series have reported promising results.

In this study, forty-four patients with AO/OTA type C2 or C3 fractures of distal humerus will be randomized to either ORIF or EHA. The patients will be examined after the operation and at 3 months and 1, 2, 5 and 10 years after the surgery. The main objective of this study is to investigate the best treatment option for distal humeral fractures in patients aged 50 years or above. This can be of value to future patients sustaining these complicated fractures.

Eligibility criteria: 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 outcomes:
measure: Oxford Elbow Score (OES)
timeFrame: 2 years after surgery.
Secondary outcomes:
measure: Mayo Elbow Performance Score (MEPS)
timeFrame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
measure: Pain severity score (VAS)
timeFrame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
measure: Range of motion
timeFrame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
measure: Patients satisfaction
timeFrame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte University Hospital
Study officials:
affiliation: Herlev and Gentofte University Hospital
name: Ali Al-Hamdani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.