Clinical trial Recruiting at 7 sites Observational Ages 18 and up

Analysis of fractures around implants and prosthetics in Spain

Official title: Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbility, Mortality, Treatment and Functional Outcome Analysis. A Prospective Multi Center Observational Collaborative Study

Run by Hospital Clínico Universitario de Valladolid · NCT04663893 · Data updated 2026-11-12

This study looks at fractures that happen around implants and prosthetics in patients across Spain to find the best ways to treat them and improve recovery.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2500 (estimated)
SponsorHospital Clínico Universitario de Valladolid
Academic / other
Locations7 sites (Barcelona and 6 other locations)
StatusRecruiting
StartedJanuary 1, 2021
Main results expectedDecember 31, 2022
Study endsDecember 31, 2027
Registry record updatedFebruary 1, 2022
Trial IDNCT04663893 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients aged 18 and older diagnosed with periprosthetic or peri-implant fractures of specific upper or lower limb bones.

Probably not a fit

Patients with fractures related to metastasis, tumors, or those involving the spine, wrist, or hand may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects and analyzes data on periprosthetic and peri-implant fractures of the upper and lower limbs across more than 70 hospitals in Spain. It aims to identify the best treatment options and clinical management strategies for these complex fractures, which often come with significant complications. By evaluating patient health status, quality of life, and treatment outcomes over one month, six months, and one year, the study seeks to establish evidence-based treatment protocols. The findings will help improve patient outcomes, reduce morbidity and mortality, and enhance overall healthcare efficiency.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for patients with periprosthetic and peri-implant fractures, enhancing recovery and quality of life.

How similar studies have gone: While there is limited clinical evidence on treatment options for these fractures, this multi-center approach aims to fill that gap, suggesting a novel and potentially impactful investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patient with the diagnose of Periprosthetic fracture of the shoulder, elbow, hip or knee. Or patients with the diagnose of Peri-implant fracture of the scapula, humerus, forearm, pelvis, femur, patella, tibia or fibula. Or patient presenting cut-out or cut-in after DHS or nail after a proximal humeral fracture.
* 18 years or older

Exclusion Criteria:

* Spine PP or PI fracture
* PP or PI secondary to metastasis or tumoral fracture
* PP or PI intraoperative fracture
* PP or PI pathologic fracture
* PP ankle fracture
* PP or PI wrist or hand fracture
* Fixation failure without any new fracture line: except cut-out or cut-in after DHS or nail of a proximal humeral fracture.
* Pregnancy

Where it's running

  • Mutua Universitaria de Tarrasa
    Barcelona, Spain
    Recruiting
  • Althaia, Xarxa Assistencial Universitària de Manresa
    Barcelona, Spain
    Recruiting
  • Hospital Clinic
    Barcelona, Spain
    Recruiting
  • Hospital Universitario Vall d´Hebrón
    Barcelona, Spain
    Recruiting
  • Hospital de Jove
    Gijón, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, Spain
    Recruiting
Show 1 more location
  • Hospital Clínico Universitario de Valladolid
    Valladolid, Spain
    Recruiting

Study contacts

  • Principal investigator: Josep M Muñoz Vives, MD PhD — Althaia Xarxa Assistencial Universitària de Manresa
  • Study coordinator: Adela Pereda-Manso
  • Email: aperedama@gmail.com
  • Phone: +34983420000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.