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Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis

Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis: Risk and Prognostic Factors

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05547867
Acronym
Prosthesis
Enrollment
60
Registered
2022-09-21
Start date
2022-09-12
Completion date
2024-09-09
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radial Head Fracture

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.

Interventions

PROCEDURERadial head prosthesis

Radial head arthroplasty in comminuted radial head fractures.

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of EHO12 monthsAssess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.
Average size of EHO12 monthsSize of EHO (measure in mm) in X-rays.
Site of EHO in elbow12 monthsLocation of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).
Osteopenia of the capitellum12 monthsThe 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 elbow12 monthsIn 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

MeasureTime frameDescription
Radial head fracture and associated elbow lesions12 monthsWe classified the radial head fracture by Mason´s classification with the Johnston modification (Fracture types I, II, III, IV) (1954).

Countries

Spain

Contacts

Primary ContactClaudia Lamas, MD, PhD
clamasg@santpau.cat935537031
Backup ContactClaudia Lamas, MD, Ph D
clamasg@santpau.cat935537032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026