Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis

Radial Head Fracture Clinical Trial

— Prosthesis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547867
• Other study ID #: IIBSP-RAD-2022-52
• Status: Recruiting
• Start date: September 12, 2022
• Est. completion date: September 9, 2024

Study information

• Verified date: September 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Claudia Lamas, MD, PhD
• Phone: 935537031
• Email: clamasg[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 9, 2024
• Est. primary completion date: June 10, 2024
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ossification, Heterotopic
• Radial Head Fracture

Intervention

Procedure:
• Radial head prosthesis
Radial head arthroplasty in comminuted radial head fractures.

Locations

Country	Name	City	State
Spain	Claudia Erika Delgado Espinoza	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (20)

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. — View Citation

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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.20 — View Citation

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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. — View Citation

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. — View Citation

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.0153 — View Citation

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

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. — View Citation

KAPICIOGLU M, SAGLAM Y, ERSEN A, ATALAR AC, DEMIRHAN 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

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. — View Citation

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. — View Citation

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

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 — View Citation

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. — View Citation

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. Erratum In: J Bone Joint Surg Am. 201 — View Citation

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. eC — View Citation

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. — View Citation

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.0b013e3181f — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of EHO	Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.	12 months
Primary	Average size of EHO	Size of EHO (measure in mm) in X-rays.	12 months
Primary	Site of EHO in elbow	Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).	12 months
Primary	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
Primary	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	Radial head fracture and associated elbow lesions	We classified the radial head fracture by Mason´s classification with the Johnston modification (Fracture types I, II, III, IV) (1954).	12 months