Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome Analysis (PIPPAS)
January 16, 2022 updated by: Héctor J Aguado, Hospital Clínico Universitario de Valladolid
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.
Study Overview
Status
Recruiting
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.
Study Type
Observational
Enrollment (Anticipated)
2500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adela Pereda-Manso
- Phone Number: 86366 +34983420000
- Email: aperedama@gmail.com
Study Contact Backup
- Name: Montsant Jornet
- Email: estudio.pippas@gmail.com
Study Locations
-
-
-
Barcelona, Spain
- Recruiting
- Hospital Clinic
-
Contact:
- Montsant Jornet
- Email: mjornet.sc@gmail.com
-
Principal Investigator:
- Pilar Camacho, MD PhD
-
Sub-Investigator:
- Montsant Jornet
-
Barcelona, Spain
- Recruiting
- Hospital Universitario Vall d´Hebrón
-
Contact:
- Jordi Teixidor, MD
- Email: jteixidorserra@gmail.com
-
Principal Investigator:
- Jordi Teixidor, MD
-
Barcelona, Spain, 08080
- Recruiting
- Mutua Universitaria de Tarrasa
-
Contact:
- Judith López Catena
- Email: jlopezcatena@mutuaterrassa.cat
-
Principal Investigator:
- Pablo Castillón, MD PhD
-
Sub-Investigator:
- Judith López Catena, PhD
-
Barcelona, Spain
- Recruiting
- ALTHAIA, Xarxa Assistencial Universitària de Manresa
-
Contact:
- Josep M Muñoz Vives, MD PhD
- Email: jmmuvi@gmail.com
-
Principal Investigator:
- Josep M Muñoz Vives, MD PhD
-
Gijón, Spain
- Recruiting
- Hospital de Jove
-
Contact:
- Pablo Garcia-Portabella, MD
- Email: pgportabella@gmail.com
-
Principal Investigator:
- Pablo Garcia-Portabella, MD
-
Madrid, Spain
- Recruiting
- Hospital Universitario 12 de Octubre
-
Contact:
- Cristina Ojeda-Thies, MD PhD
- Email: ojedathies@gmail.com
-
Principal Investigator:
- Cristina Ojeda-Thies, MD PhD
-
Valladolid, Spain, 47007
- Recruiting
- Hospital Clínico Universitario de Valladolid
-
Contact:
- Adela Pereda Manso
- Phone Number: 86366 +34983420000
- Email: estudio.pippas@gmail.com
-
Principal Investigator:
- Héctor J Aguado, MD PhD
-
Sub-Investigator:
- Adela Pereda
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: Up to 12 months
|
Rate of mortality at anytime from fracture diagnose up to 12 months
|
Up to 12 months
|
|
Fracture classification
Time Frame: Pre-operatively (Day -1)
|
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
Time Frame: Post-operatively (Day +1)
|
Number of patients treated with fixation or revision and fixation or implant removal
|
Post-operatively (Day +1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fracture healing
Time Frame: Up to 12 months
|
Rate of bone union on X-rays
|
Up to 12 months
|
|
Health related quality of life
Time Frame: Up to 12 months
|
EuroQuality of Life 5Dimensions 5Leves (EQ5D5L)
|
Up to 12 months
|
|
Dependency
Time Frame: Up to 12 months
|
Clinical frailty scale (1-9) 1=very fit, 9=terminally ill
|
Up to 12 months
|
|
Mental situation
Time Frame: Up to 12 months
|
Pfeiffer test
|
Up to 12 months
|
|
Gait
Time Frame: Up to 12 months
|
FFN-MCD mobility scale (Fragility Fracture Network-Minimum Common Dataset).
1-5: 1=independent mobility, 5=No functional mobility
|
Up to 12 months
|
|
Bone protector treatment
Time Frame: Up to 12 months
|
Is the patient under treatment with vitamine D, calcium, bone formation, bone modeling?
|
Up to 12 months
|
|
Life style change
Time Frame: Up to 12 months
|
Need to change place of living because of the fracture or its sequels.
|
Up to 12 months
|
|
Medical or Surgical complications
Time Frame: Up to 12 months
|
in need of at least one in-hospital night.
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Héctor J Aguado, MD PhD, Hospital Clínico Universitario Valladolid
- Study Director: Pablo Castillón, MD PhD, Mútua Universitaria de Terrassa
- Principal Investigator: 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2027
Study Registration Dates
First Submitted
December 4, 2020
First Submitted That Met QC Criteria
December 5, 2020
First Posted (Actual)
December 11, 2020
Study Record Updates
Last Update Posted (Actual)
February 1, 2022
Last Update Submitted That Met QC Criteria
January 16, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI 20-2041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
From 1st of January 2022
IPD Sharing 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.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periprosthetic Fractures
-
Brugmann University HospitalCompletedPeriprosthetic Fracture of the FemurBelgium
-
AO Innovation Translation CenterRecruitingPeriprosthetic Fractures | Periprosthetic Fracture Around Prosthetic Joint ImplantUnited States, Germany, Switzerland, Belgium, Colombia, Spain
-
Assiut UniversityNot yet recruitingArthroplasty Complications | Periprosthetic Fracture of Hip
-
Aesculap AGCompletedPeriprosthetic Fracture Around Prosthetic Joint Implant | Aseptic Loosening of Prosthetic JointGermany
-
Medical University of ViennaCompleted
-
Unity Health TorontoRecruitingKnee Fracture | Distal Femur Fracture | Periprosthetic Fracture Around Prosthetic Joint Implant KneeCanada
-
Unity Health TorontoRecruiting
-
Hebei Medical University Third HospitalUnknown
-
Peking University People's HospitalUnknown
-
Sundsvall HospitalKarolinska Institutet; Sunderby HospitalCompletedFemoral Neck Fractures | Periprosthetic Fractures