Clinical trial NCT05547867: Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis
Official title: Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis: Risk and Prognostic Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radial Head Fracture
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study will include consecutive patients admitted to our hospital Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) elected for radial head arthroplasty due to elbow fractures from 2010 to 2020. All patients will be included retrospectively through our hospital patient electronic health records.

Brief summary: Elbow heterotopic ossification (EHO) is described as the formation of ectopic bone in tissues not supposed to around elbow. The EHO physiopathology, yet not clarified, has been suggested to be a multifactorial process in which immune system, inflammatory response, CNS and tissue expressed proteins after severe trauma boost hyperactive metabolically bone with no periosteal layer. Consistent with that, EHO has been widely related to elbow trauma, including bone, ligament, muscle or joint; iatrogenic trauma, including epicondylectomy or elbow arthroplasty; neural injuries or burns. Clinical manifestations of EHO has been reported as limited range of motion (ROM), muscle, nerve or joint pain, stiffness and ankylosis all of them leading to upper extremity disfucntion. Prevalence of EHO can range from 3%-45% depending on degree of elbow injury. To our knowledge, prevalence of EHO among radial head fractures had not been assessed previously.

Detailed description: Prevention of EHO has been proposed to be managed with a range of nonsurgical treatment options such as: radiotherapy, NSAIDS and biphosphonate. However, none of them had become clear effective above others, and only surgical excision of EHO had become a reliable option to overcome its associated limitations in elbow motion. Classic approaches suggested delayed surgery until maturity of heterotopic bone, however recent literature suggest early excisions of immature ossification to obtain favorable functional results.

Several studies have investigated risk factors of EHO regarding the high patient burden and health costs to which is associated, however, few published data exists about prevalence and risk factors of EHO after radial head arthroplasty.

Our aim is to assess the prevalence and predictor factors that can lead to EHO after radial arthroplasty in order to be able to predict and apply early preventive treatment to improve postoperative functional outcomes among patients with severe radial head fractures.

Eligibility criteria: Inclusion Criteria:

* Adults between 18-85 years-old
* Comminuted radial head fractures treated with radial head arthroplasty

Exclusion Criteria:

* Younger than 18 years; Older than 85 years
* History of previous elbow injuries or operations.
* Pathologic fractures
* Infections

Primary outcomes:
measure: Prevalence of EHO
timeFrame: 12 months
measure: Average size of EHO
timeFrame: 12 months
measure: Site of EHO in elbow
timeFrame: 12 months
measure: Osteopenia of the capitellum
timeFrame: 12 months
measure: Degenerative changes of the elbow
timeFrame: 12 months
Secondary outcomes:
measure: Radial head fracture and associated elbow lesions
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Claudia Erika Delgado Espinoza
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: HSCSP
name: Claudia Lamas, MD Ph D
role: PRINCIPAL_INVESTIGATOR
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