Radial Head FractureProsthesisNCT05547867
Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis
An observational study of Radial Head Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Radial Head Fracture
- What is being tested?
- Radial head prosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 12 Sep 2022to 9 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adults between 18-85 years-old
- Comminuted radial head fractures treated with radial head arthroplasty
Who cannot join
- Younger than 18 years; Older than 85 years
- History of previous elbow injuries or operations.
- Pathologic fractures
- Infections
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Claudia Erika Delgado Espinoza
Barcelona, 08025
Claudia Erika Delgado Espinoza, MD, Ph D, 935537634, CDelgadoE@santpau.cat
Claudia Erika Delgado Espinoza, MD, Ph D, CDelgadoE@santpau.cat
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Claudia Lamas, MD PhD, +34935537031, clamasg@santpau.cat
Claudia Lamas, MD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Radial Head Fracture
- Being tested
- Radial head prosthesis
- Medical subject headings
- Radial Head and Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial head prosthesisProcedure or surgery
Radial head arthroplasty in comminuted radial head fractures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of EHO
Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.
Measured: 12 months
Average size of EHO
Size of EHO (measure in mm) in X-rays.
Measured: 12 months
Site of EHO in elbow
Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).
Measured: 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).
Measured: 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).
Measured: 12 months
Secondary outcomes (1)
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start12 Sep 2022
- Primary completion10 Jun 2024 (estimated)
- Study completion9 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Radial Head FractureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Lamas, MD Ph D, Principal investigator, HSCSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547867
- Sponsor's protocol ID
- IIBSP-RAD-2022-52
- Acronym
- Prosthesis
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol for the collection of radiological data and possible risk and prognostic factors associated with the presence of EHO in radial head arthroplasty.
Publications
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.
PubMed 27886681Qazi 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
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.
PubMed 9219141Agarwal 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.
PubMed 28363301Robinson 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.
PubMed 29855240Baldwin 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.
PubMed 21458925KAPICIOĞLU 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
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.
PubMed 23677367van 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.
PubMed 21321512Salazar 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.
PubMed 24711127Ploumis 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.
PubMed 24138821Garland DE. A clinical perspective on common forms of acquired heterotopic ossification. Clin Orthop Relat Res. 1991 Feb;(263):13-29.
PubMed 1899635Suito 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.
PubMed 32158828Wiggers 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.
PubMed 24078170Abrams 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.
PubMed 22947234
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis: Risk and Prognostic Factors
- ClinicalTrials.gov ID
- NCT05547867
- Acronym / sponsor ID
- Prosthesis / IIBSP-RAD-2022-52
- Conditions
- Radial Head Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 9 Sep 2024 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults between 18-85 years-old
- Comminuted radial head fractures treated with radial head arthroplasty
Key exclusion criteria (4 listed)
- Younger than 18 years; Older than 85 years
- History of previous elbow injuries or operations.
- Pathologic fractures
- Infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial head prosthesisRadial head arthroplasty in comminuted radial head fractures. | Procedure or surgery | – |
Primary outcome
Prevalence of EHO
Time frame: 12 months
Assess prevalence of EHO after radial head arthroplasty in anteroposterior and lateral radiographs.
Average size of EHO
Time frame: 12 months
Size of EHO (measure in mm) in X-rays.
Site of EHO in elbow
Time frame: 12 months
Location of EHO in elbow anteroposterior and lateral X-rays (anterior, posterior, medial, lateral).
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).
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).
1 secondary outcome
Radial head fracture and associated elbow lesions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Results publication: PubMed 27886681Barfield 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.
- Results publicationQazi 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
- Results publication: PubMed 9219141Summerfield 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.
- Results publication: PubMed 28363301Agarwal 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.
- Results publication: PubMed 29855240Robinson 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.
- Results publication: PubMed 21458925Baldwin 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.
- Results publicationKAPICIOĞLU 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
- Results publication: PubMed 23677367Foruria 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.
- Results publication: PubMed 21321512van 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.
- Results publication: PubMed 24711127Salazar 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.
- Results publication: PubMed 24138821Ploumis 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.
- Results publication: PubMed 1899635Garland DE. A clinical perspective on common forms of acquired heterotopic ossification. Clin Orthop Relat Res. 1991 Feb;(263):13-29.
- Individual participant dataSharing planned: No. Protocol for the collection of radiological data and possible risk and prognostic factors associated with the presence of EHO in radial head arthroplasty.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Lamas, MD Ph D principal investigator
HSCSP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Head Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Lamas, MD, PhD (935537031, clamasg@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of EHO (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05547867, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.