An observational study in Radial Head Fracture, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 2 sites in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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.
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.
30 studies on the registry are indexed under Ossification, Heterotopic; 8 are open to participants now.
Browse Ossification, Heterotopic studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
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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.
Exclusion Criteria:
Radial head arthroplasty in comminuted radial head fractures.
Prevalence of EHO
Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.
Time frame: 12 months
Average size of EHO
Size of EHO (measure in mm) in X-rays.
Time frame: 12 months
Site of EHO in elbow
Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).
Time frame: 12 months
Osteopenia of the capitellum
The radiographs of the elbow will be review for osteopenia of the capitellum, and graded as none, mild, moderate, or severe according to the system of Lamas et al. (2011).
Time frame: 12 months
Degenerative changes of the elbow
In anteroposterior and lateral X-rays. For the degree of degenerative change of the elbow, classified as Grade 0 (normal joint), Grade 1 (slight joint, space narrowing and minimum osteophyte formation), Grade 2 (moderate joint space narrowing and moderate osteophyte formation), or Grade 3 (severe degenerative changes with gross destruction of the joint) according to the system of Broberg and Morrey (1986).
Time frame: 12 months
Radial head fracture and associated elbow lesions
We classified the radial head fracture by Mason´s classification with the Johnston modification (Fracture types I, II, III, IV) (1954).
Time frame: 12 months
Plan to share: No — Protocol for the collection of radiological data and possible risk and prognostic factors associated with the presence of EHO in radial head arthroplasty.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau