Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis (Prosthesis)

March 20, 2024 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Claudia Lamas, MD PhD
      • Barcelona, Spain, 08025
        • Recruiting
        • Claudia Erika Delgado Espinoza
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of EHO
Time Frame: 12 months
Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.
12 months
Average size of EHO
Time Frame: 12 months
Size of EHO (measure in mm) in X-rays.
12 months
Site of EHO in elbow
Time Frame: 12 months
Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).
12 months
Osteopenia of the capitellum
Time Frame: 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).
12 months
Degenerative changes of the elbow
Time Frame: 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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radial head fracture and associated elbow lesions
Time Frame: 12 months
We classified the radial head fracture by Mason´s classification with the Johnston modification (Fracture types I, II, III, IV) (1954).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Claudia Lamas, MD Ph D, HSCSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Estimated)

June 10, 2024

Study Completion (Estimated)

September 9, 2024

Study Registration Dates

First Submitted

September 11, 2022

First Submitted That Met QC Criteria

September 18, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-RAD-2022-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protocol for the collection of radiological data and possible risk and prognostic factors associated with the presence of EHO in radial head arthroplasty.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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