Assessing bone growth issues after elbow surgery for fractures
Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis: Risk and Prognostic Factors
This study looks at how common bone growth problems are after elbow surgery for fractures and what factors might cause them, to help improve recovery for adults aged 18 to 85.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 2 sites (Barcelona and 1 other locations) |
| Trial ID | NCT05547867 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence and risk factors of elbow heterotopic ossification (EHO) in adults who have undergone radial head arthroplasty due to comminuted radial head fractures. The research will analyze how various factors contribute to the development of EHO, which can lead to complications such as limited range of motion and pain. By identifying predictors of EHO, the study seeks to inform early preventive treatments that could enhance postoperative functional outcomes for patients. The study will involve adult participants aged 18 to 85 years who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-85 with comminuted radial head fractures treated with radial head arthroplasty.
Not a fit: Patients with a history of previous elbow injuries or operations, pathologic fractures, or infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative care and outcomes for patients with severe radial head fractures.
How similar studies have performed: While there have been studies on EHO, this specific focus on radial head fractures and their prevalence is novel and has not been extensively researched.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona and 1 other locations
- Claudia Erika Delgado Espinoza — Barcelona, Spain (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Claudia Lamas, MD Ph D — Hscsp
- Study coordinator: Claudia Lamas, MD, PhD
- Email: clamasg@santpau.cat
- Phone: 935537031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.