NCT04663893

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2021Dec 2027

First Submitted

Initial submission to the registry

December 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

December 4, 2020

Last Update Submit

January 16, 2022

Conditions

Periprosthetic Fracture of the Upper or Lower LimbPeri-implant Fracture of the Upper or Lower LimbPeriprosthetic FracturesPeri-implant Fracture

Keywords

Periprosthetic fractureperi-implant fracturemortalitymorbiditylooseningprosthesis revisionfixationosteosynthesiscomplicationambulatequality of life

Outcome Measures

Primary Outcomes (3)

  • Mortality

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

    Up to 12 months

  • 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

    Pre-operatively (Day -1)

  • Treatment

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

    Post-operatively (Day +1)

Secondary Outcomes (8)

  • Fracture healing

    Up to 12 months

  • Health related quality of life

    Up to 12 months

  • Dependency

    Up to 12 months

  • Mental situation

    Up to 12 months

  • Gait

    Up to 12 months

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.
  • years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mutua Universitaria de Tarrasa

Barcelona, 08080, 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

Hospital Clínico Universitario de Valladolid

Valladolid, 47007, Spain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 41428314DERIVED

  • 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.

    PMID: 38451303DERIVED

MeSH Terms

Conditions

Periprosthetic Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Héctor J Aguado, MD PhD

    Hospital Clínico Universitario Valladolid

    STUDY DIRECTOR

  • Pablo Castillón, MD PhD

    Mútua Universitaria de Terrassa

    STUDY DIRECTOR

  • Josep M Muñoz Vives, MD PhD

    Althaia Xarxa Assistencial Universitària de Manresa

    PRINCIPAL INVESTIGATOR

  • Cristina Ojeda-Thies, MD PhD

    Hospital 12 de Octubre, Madrid

    PRINCIPAL INVESTIGATOR

  • Pilar Camacho, MD PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Jordi Teixidor, MD

    Hospital Universitario Vall d´Hebrón

    PRINCIPAL INVESTIGATOR

  • Pablo García-Portablella, MD

    Hospital de Jove, Gijón

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adela Pereda-Manso

CONTACT

+34983420000aperedama@gmail.com

Montsant Jornet

CONTACT

estudio.pippas@gmail.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Associate Professor Trauma/Orthogeriatric unit

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 11, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2027

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
From 1st of January 2022
Access Criteria
Application form to the PIPPAS study office. The applicant must be a study participant and should describe which is the substudy to be held, providing a detailed description and variables need for that reason.

Locations

ES(7)