Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05547867
Collaborator
(none)
60
2
8.5
30
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radial head prosthesis

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis: Risk and Prognostic Factors
Anticipated Study Start Date :
Sep 12, 2022
Anticipated Primary Completion Date :
Apr 28, 2023
Anticipated Study Completion Date :
May 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Prevalence of EHO [12 months]

    Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.

  2. Average size of EHO [12 months]

    Size of EHO (measure in mm) in X-rays.

  3. Site of EHO in elbow [12 months]

    Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).

  4. 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).

  5. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Claudia Erika Delgado Espinoza Barcelona Spain 08025
2 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT05547867
Other Study ID Numbers:
  • IIBSP-RAD-2022-52
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 21, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2022