Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis

NCT05547867 | Unknown

• 1 other identifier: IIBSP-RAD-2022-52
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Radial Head Fracture

Outcome Measures

Primary Outcomes (5)

• Prevalence of EHO

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

  12 months

• Average size of EHO

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

  12 months

• Site of EHO in elbow

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

  12 months

• 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

• 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 Outcomes (1)

• Radial head fracture and associated elbow lesions

  12 months

Interventions

Radial head prosthesis PROCEDURE

Radial head arthroplasty in comminuted radial head fractures.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults between 18-85 years-old
• Comminuted radial head fractures treated with radial head arthroplasty

You may not qualify if:

• Younger than 18 years; Older than 85 years
• History of previous elbow injuries or operations.
• Pathologic fractures
• Infections

Sponsors & Collaborators

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

Study Sites (2)

Claudia Erika Delgado Espinoza

Barcelona, 08025, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Related Publications (20)

• Barfield WR, Holmes RE, Hartsock LA. Heterotopic Ossification in Trauma. Orthop Clin North Am. 2017 Jan;48(1):35-46. doi: 10.1016/j.ocl.2016.08.009. Epub 2016 Oct 28.

  PMID: 27886681 RESULT

• Qazi S, Reynolds J, Abdelfattah H, Thoder J. Heterotopic Ossification of the Elbow: A Literature Review. J Adv Med Med Res. August 2019:1-10. doi:10.9734/JAMMR/2019/V30I630207

  RESULT

• Summerfield SL, DiGiovanni C, Weiss AP. Heterotopic ossification of the elbow. J Shoulder Elbow Surg. 1997 May-Jun;6(3):321-32. doi: 10.1016/s1058-2746(97)90025-2. No abstract available.

  PMID: 9219141 RESULT

• Agarwal S, Loder S, Levi B. Heterotopic Ossification Following Upper Extremity Injury. Hand Clin. 2017 May;33(2):363-373. doi: 10.1016/j.hcl.2016.12.013.

  PMID: 28363301 RESULT

• Robinson PM, MacInnes SJ, Stanley D, Ali AA. Heterotopic ossification following total elbow arthroplasty: a comparison of the incidence following elective and trauma surgery. Bone Joint J. 2018 Jun 1;100-B(6):767-771. doi: 10.1302/0301-620X.100B6.BJJ-2017-0535.R2.

  PMID: 29855240 RESULT

• Baldwin K, Hosalkar HS, Donegan DJ, Rendon N, Ramsey M, Keenan MA. Surgical resection of heterotopic bone about the elbow: an institutional experience with traumatic and neurologic etiologies. J Hand Surg Am. 2011 May;36(5):798-803. doi: 10.1016/j.jhsa.2011.01.015. Epub 2011 Apr 2.

  PMID: 21458925 RESULT

• KAPICIOĞLU M, SAĞLAM Y, ERŞEN A, ATALAR AC, DEMİRHAN M, DURMAZ H. Does Resection of Heterotopic Ossification of the Elbow Result in Satisfactory Functional Outcomes? Bezmialem Sci. 2019;7(2):124-131. doi:10.14235/bas.galenos.2018.2467

  RESULT

• Foruria AM, Augustin S, Morrey BF, Sanchez-Sotelo J. Heterotopic ossification after surgery for fractures and fracture-dislocations involving the proximal aspect of the radius or ulna. J Bone Joint Surg Am. 2013 May 15;95(10):e66. doi: 10.2106/JBJS.K.01533.

  PMID: 23677367 RESULT

• van Kampen PJ, Martina JD, Vos PE, Hoedemaekers CW, Hendricks HT. Potential risk factors for developing heterotopic ossification in patients with severe traumatic brain injury. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):384-91. doi: 10.1097/HTR.0b013e3181f78a59.

  PMID: 21321512 RESULT

• Salazar D, Golz A, Israel H, Marra G. Heterotopic ossification of the elbow treated with surgical resection: risk factors, bony ankylosis, and complications. Clin Orthop Relat Res. 2014 Jul;472(7):2269-75. doi: 10.1007/s11999-014-3591-0. Epub 2014 Apr 8.

  PMID: 24711127 RESULT

• Ploumis A, Belbasis L, Ntzani E, Tsekeris P, Xenakis T. Radiotherapy for prevention of heterotopic ossification of the elbow: a systematic review of the literature. J Shoulder Elbow Surg. 2013 Nov;22(11):1580-8. doi: 10.1016/j.jse.2013.07.045.

  PMID: 24138821 RESULT

• Garland DE. A clinical perspective on common forms of acquired heterotopic ossification. Clin Orthop Relat Res. 1991 Feb;(263):13-29.

  PMID: 1899635 RESULT

• Suito M, Yuzuriha S, Iwasawa M, Yanagisawa D, Kinjo Y, Takashimizu I, Hoshino Y. Therapeutic strategies for elbow ankylosis due to heterotopic ossification in patients with severe burns. JPRAS Open. 2018 Jul 5;17:24-30. doi: 10.1016/j.jpra.2018.06.004. eCollection 2018 Sep.

  PMID: 32158828 RESULT

• Wiggers JK, Helmerhorst GT, Brouwer KM, Niekel MC, Nunez F, Ring D. Injury complexity factors predict heterotopic ossification restricting motion after elbow trauma. Clin Orthop Relat Res. 2014 Jul;472(7):2162-7. doi: 10.1007/s11999-013-3304-0.

  PMID: 24078170 RESULT

• Abrams GD, Bellino MJ, Cheung EV. Risk factors for development of heterotopic ossification of the elbow after fracture fixation. J Shoulder Elbow Surg. 2012 Nov;21(11):1550-4. doi: 10.1016/j.jse.2012.05.040. Epub 2012 Sep 2.

  PMID: 22947234 RESULT

• Bauer AS, Lawson BK, Bliss RL, Dyer GS. Risk factors for posttraumatic heterotopic ossification of the elbow: case-control study. J Hand Surg Am. 2012 Jul;37(7):1422-9.e1-6. doi: 10.1016/j.jhsa.2012.03.013. Epub 2012 May 1.

  PMID: 22551954 RESULT

• Hong CC, Nashi N, Hey HW, Chee YH, Murphy D. Clinically relevant heterotopic ossification after elbow fracture surgery: a risk factors study. Orthop Traumatol Surg Res. 2015 Apr;101(2):209-13. doi: 10.1016/j.otsr.2014.10.021. Epub 2015 Feb 18.

  PMID: 25701160 RESULT

• Schnetzke M, Porschke F, Hoppe K, Studier-Fischer S, Gruetzner PA, Guehring T. Outcome of Early and Late Diagnosed Essex-Lopresti Injury. J Bone Joint Surg Am. 2017 Jun 21;99(12):1043-1050. doi: 10.2106/JBJS.16.01203.

  PMID: 28632594 RESULT

• Broberg MA, Morrey BF. Results of delayed excision of the radial head after fracture. J Bone Joint Surg Am. 1986 Jun;68(5):669-74.

  PMID: 3722222 RESULT

• Lamas C, Castellanos J, Proubasta I, Dominguez E. Comminuted radial head fractures treated with pyrocarbon prosthetic replacement. Hand (N Y). 2011 Mar;6(1):27-33. doi: 10.1007/s11552-010-9282-8. Epub 2010 Jun 15.

  PMID: 22379435 RESULT

MeSH Terms

Conditions

Radial Head and Neck Fractures

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Radius Fractures; Forearm Injuries; Fractures, Bone

Study Officials

• Claudia Lamas, MD Ph D

  HSCSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Lamas, MD, PhD

CONTACT

935537031; clamasg@santpau.cat

Claudia Lamas, MD, Ph D

CONTACT

935537032; clamasg@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 21, 2022
• Study Start: September 12, 2022
• Primary Completion: June 10, 2024
• Study Completion: September 9, 2024
• Last Updated: March 21, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)