Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis
- Conditions
- Radial Head Fracture
- Registration Number
- NCT05547867
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Adults between 18-85 years-old
- Comminuted radial head fractures treated with radial head arthroplasty
- Younger than 18 years; Older than 85 years
- History of previous elbow injuries or operations.
- Pathologic fractures
- Infections
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of EHO 12 months Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.
Site of EHO in elbow 12 months Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).
Average size of EHO 12 months Size of EHO (measure in mm) in X-rays.
Osteopenia of the capitellum 12 months 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).
Degenerative changes of the elbow 12 months 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).
- Secondary Outcome Measures
Name Time Method Radial head fracture and associated elbow lesions 12 months We classified the radial head fracture by Mason´s classification with the Johnston modification (Fracture types I, II, III, IV) (1954).
Trial Locations
- Locations (2)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Claudia Erika Delgado Espinoza
🇪🇸Barcelona, Spain