Radial Head Fracture Clinical Trial
— ProsthesisOfficial title:
Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis: Risk and Prognostic Factors
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 9, 2024 |
Est. primary completion date | June 10, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Claudia Erika Delgado Espinoza | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of EHO | Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs. | 12 months | |
Primary | Average size of EHO | Size of EHO (measure in mm) in X-rays. | 12 months | |
Primary | Site of EHO in elbow | Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral). | 12 months | |
Primary | 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). | 12 months | |
Primary | 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). | 12 months | |
Secondary | Radial head fracture and associated elbow lesions | We classified the radial head fracture by MasonĀ“s classification with the Johnston modification (Fracture types I, II, III, IV) (1954). | 12 months |
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