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Periprosthetic Fracture of the Upper or Lower LimbPIPPASNCT04663893

Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome Analysis

An observational study of Periprosthetic Fracture of the Upper or Lower Limb and Peri-implant Fracture of the Upper or Lower Limb, run by Hospital Clínico Universitario de Valladolid at 7 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study supports Spanish data collection and analysis on Periprosthetic and Peri-implant fractures of the upper and lower limb. Treatment and clinical management of this fractures are complex and goes along with complications. There will be more than 70 hospitals providing information. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,500 participants
Where
7 sitesSpain
Study dates
1 Jan 2021to 31 Dec 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients treated for a Periprosthetic or a Peri-implant fracture of the upper or lower limb by any participant hospital in Spain. Hospital participation is voluntary and upon request or invitation. 80 hospitals participating all over Spain

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Adela Pereda-Manso contact

+34983420000 ext. 86366

aperedama@gmail.com

Montsant Jornet contact

estudio.pippas@gmail.com

7 sites in 1 country

Spain7 sites, 7 recruiting

  • Mutua Universitaria de Tarrasa

    Barcelona, 08080

    Judith López Catena, jlopezcatena@mutuaterrassa.cat

    Pablo Castillón, MD PhD

    Recruiting

  • Althaia, Xarxa Assistencial Universitària de Manresa

    Barcelona

    Josep M Muñoz Vives, MD PhD, jmmuvi@gmail.com

    Josep M Muñoz Vives, MD PhD

    Recruiting

  • Hospital Clinic

    Barcelona

    Montsant Jornet, mjornet.sc@gmail.com

    Pilar Camacho, MD PhD

    Recruiting

  • Hospital Universitario Vall d´Hebrón

    Barcelona

    Jordi Teixidor, MD, jteixidorserra@gmail.com

    Jordi Teixidor, MD

    Recruiting

  • Hospital de Jove

    Gijón

    Pablo Garcia-Portabella, MD, pgportabella@gmail.com

    Pablo Garcia-Portabella, MD

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Cristina Ojeda-Thies, MD PhD, ojedathies@gmail.com

    Cristina Ojeda-Thies, MD PhD

    Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47007

    Adela Pereda Manso, +34983420000 ext. 86366, estudio.pippas@gmail.com

    Héctor J Aguado, MD PhD

    Recruiting

Other trials in Spain

About this study

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

This study supports Spanish data collection and analysis on Periprosthetic and Peri-implant fractures of the upper and lower limb. Treatment and clinical management of this fractures are complex and goes along with complications. There will be more than 70 hospitals providing information. This study will provide evidence on which is the best treatment for every unique patient. This will help trauma surgeons and geriatricians to provide better treatments, to improve health care in our society, reducing mortality, morbidity, improving functional outcomes, and reducing costs, which in turn will be advances in trauma care.

Read the detailed description

There is no clinical evidence on which are the best treatment options for Periprosthetic and Peri-implant fractures of the upper and lower limb. This is a multi-center collaborative study seeking to obtain a big number of patients. Data collection includes previous health status and quality of life, which is the clinical management and treatment, as well as the outcome after one month, six months and one year. The investigators will be able to define risk factors and clinical attitudes, which influence on the patient outcome. And therefore, be able to establish treatment protocols and give management recommendations based on the observed clinical evidence to improve healing indexes, morbidity and mortality, function, grade of autonomy and quality of live.

Main questions to be answered are: 1. which is the epidemiology of Periprosthetic and Peri-implant fractures and how are they treated in Spain, 2. Identify risk factors for complications and worse outcomes, 3. which is the morbidity and mortality, 4. influence of the fracture type and implants already placed on management and outcome, 5. influence of the treatment on patients' grade of independency, and 6. identified which are the risk factors for treatment failure.

Keywords
Periprosthetic fracture, peri-implant fracture, mortality, morbidity, loosening, prosthesis revision, fixation, osteosynthesis, complication, ambulate, quality of life
Medical subject headings
Periprosthetic Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Rate of mortality at anytime from fracture diagnose up to 12 months

    Measured: Up to 12 months

  2. Fracture classification

    Fracture classification using the UCS for periprosthetic fractures, and the adapted H. Broggi classification for peri-implant fractures. Number of patients in each classification group

    Measured: Pre-operatively (Day -1)

  3. Treatment

    Number of patients treated with fixation or revision and fixation or implant removal

    Measured: Post-operatively (Day +1)

Secondary outcomes (8)

  1. Fracture healing

    Rate of bone union on X-rays

    Measured: Up to 12 months

  2. Health related quality of life

    EuroQuality of Life 5Dimensions 5Leves (EQ5D5L)

    Measured: Up to 12 months

  3. Dependency

    Clinical frailty scale (1-9) 1=very fit, 9=terminally ill

    Measured: Up to 12 months

  4. Mental situation

    Pfeiffer test

    Measured: Up to 12 months

  5. Gait

    FFN-MCD mobility scale (Fragility Fracture Network-Minimum Common Dataset). 1-5: 1=independent mobility, 5=No functional mobility

    Measured: Up to 12 months

  6. Bone protector treatment

    Is the patient under treatment with vitamine D, calcium, bone formation, bone modeling?

    Measured: Up to 12 months

  7. Life style change

    Need to change place of living because of the fracture or its sequels.

    Measured: Up to 12 months

  8. Medical or Surgical complications

    in need of at least one in-hospital night.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Ecologic or community
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04663893
Sponsor's protocol ID
PI 20-2041
Acronym
PIPPAS
Status last verified
Jan 2022
First submitted
4 Dec 2020
Last updated
1 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • Moreta J, Aguado HJ, Castillon-Bernal P, Munoz-Vives JM, Camacho P, Jornet-Gibert M, Teixidor J, Pereda-Manso A, Garcia-Sanchez Y, Ojeda-Thies C, Garcia-Portabella P, Alvarez EM, Noriega-Gonzalez D, Munoz-Moreno MF, Arroyo-Hernantes I, Alvarez-Ramos BA, Garcia-Medrano B, Martinez-Selles C, Marin-Jimenez S, Garcia-Virto V, Pais-Ortega S, Acha A, Tomas-Hernandez J, Selga-Marsa J, Andres-Peiro JV, Piedra-Calle C, Blasco-Casado F, Guerra-Farfan E, Querolt-Coll J, de Santamaria GT, Hernandez JM, Renau-Cerrillo M, Gil-Aliberas C, Carreras-Castaner A, Vives-Barquiel M, Fernandez EA, Manzano EF, De Cortazar UG, Arrieta M, Escobar D, Castrillo E, Balvis Balvis P, Denisiuk M, Menendez MC, Pastor S, Larrazabal A, Olias-Lopez B, Amaya-Espinosa P, Boluda-Mengod J, Gonzalez-Martin D, Lopez-Dorado D, Borras-Cebrian JC, Martinez-Perez C, Pazmino PAF, Calavia-Cale P, Suarez-Suarez MA, Lanuza-Lagunilla L, Arias AG, Cabria-Fernandez J, Garcia-Coiradas J, Valle-Cruz J, Del Saz JS, Mora-Fernandez J, Lalueza-Andreu P, Bonome-Roel C, Cano-Leira MA, Carrasco AB, Pariza AL, Fernandez-Juan A, la Puente CS, Juldain-Mondragon M, Arsuaga JG, Saura-Sanchez E, Gimenez-Ibanez S, Sanchez-Gomez P, Ricon-Recarey FJ, Garcia Garcia EM, Cuadrado-Abajo F, Perez-Nunez MI, Del Pozo-Manrique P, Navas-Garcia FMG, Garcia-Paredero E, Guijarro-Valtuena A, Robles TB, Navas-Pernia I, De Villasante-Jiron I, Porta TS, Becerra CC, Otero-Naveiro V, Paz SP, Castrillo IF, Fernandez-Dorado F, Martinez-Menduina A, Vaquerizo-Garcia V, Murcia-Asensio A, Galian-Munoz E, Marin-Martinez C, Munoz-Vicente A, Plaza-Salazar N, Gamez-Asuncion C, Benito-Santamaria J, Salgado-Tarrida P, Prats-Puente O, Cuenca-Copete A, Gonzalez-Montero B, Giraldo-Vegas LA, Mingo-Robinet J, Briso-Montiano R, Barberia-Biurrun A, Escudero-Martinez E, Chouza-Montero L, Naharro-Tobio M, Gasset-Teixidor A, Dominguez-Ibarrola A, Penalver JM, Serrano-Sanz J, Roche-Albero A, Martin-Hernandez C, Macho-Mier M, Salo-Cuenca JC, Rosello JE, Criado-Albillos G, Cabello-Benavides HG, Nestar DA, Gonzalez-Bernal J, Gonzalez-Santos J, Cunchillos-Pascual J, Blasco JM, Bogallo-Dorado JM, Ramirez-Roldan A, Cano-Porras JR, Marques-Lopez F, Martinez-Diaz S, Slullitel PI, Carabelli GS, Astore I, Boietti BR, Cordova-Peralta JC, Hernandez-Pascual C, Rodriguez-Gangoso A, Dot-Pascuet I, Pineiro-Borrero A, Perez-Sanchez JM, Mandia-Martinez A, De Caso-Rodriguez J, Martin-Marcuello J, Benito-Mateo M, Alda-Gastiain O, Corcuera-Elosegui I, Gonzalez-Panisello MR, Perez-Salazar NE, De Sande-Diaz M. Internal fixation versus revision arthroplasty for Vancouver B2-B3 fractures: mortality and functional outcomes in frail patients. Insights from the PIPPAS study of 485 patients. J Orthop Traumatol. 2025 Dec 22;26(1):78. doi: 10.1186/s10195-025-00886-3.

    PubMed 41428314

  • PIPPAS Study Group. Optimizing periprosthetic fracture management and in-hospital outcome: insights from the PIPPAS multicentric study of 1387 cases in Spain. J Orthop Traumatol. 2024 Mar 7;25(1):13. doi: 10.1186/s10195-024-00746-6.

    PubMed 38451303

Questions about this trial

What is this clinical trial studying?

An observational study of Periprosthetic Fracture of the Upper or Lower Limb and Peri-implant Fracture of the Upper or Lower Limb, run by Hospital Clínico Universitario de Valladolid at 7 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 8 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: looking for participants now, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adela Pereda-Manso (+34983420000 ext. 86366, aperedama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Up to 12 months). The study lists 3 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 NCT04663893, which also lists 2 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 1 Feb 2022.

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