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NCT05547867: Prosthesis
Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis
trial testing Radial head prosthesis in Radial Head Fracture in 60 participants. Status unknown.
10 June 2024
Quick facts
| Lead sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 12 September 2022 |
| Primary completion | 10 June 2024 |
| Estimated completion | 9 September 2024 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Radial head prosthesis
Conditions studied
- Radial Head Fracture — all drugs for Radial Head Fracture →
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Who can join
Adults 18 to 85, any sex, with Radial Head Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05547867
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05547867 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Last refreshed: 21 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05547867.
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