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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Periprosthetic Fracture of the Upper or Lower Limb, Peri-implant Fracture of the Upper or Lower Limb, Periprosthetic Fractures, Peri-implant Fracture

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture healing | Rate of bone union on X-rays | Up to 12 months | 
| Health related quality of life | EuroQuality of Life 5Dimensions 5Leves (EQ5D5L) | Up to 12 months | 
| Dependency | Clinical frailty scale (1-9) 1=very fit, 9=terminally ill | Up to 12 months | 
| Mental situation | Pfeiffer test | Up to 12 months | 
| Gait | 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 | Is the patient under treatment with vitamine D, calcium, bone formation, bone modeling? | Up to 12 months | 
| Life style change | Need to change place of living because of the fracture or its sequels. | Up to 12 months | 
| Medical or Surgical complications | in need of at least one in-hospital night. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periprosthetic fracture, peri-implant fracture, mortality, morbidity, loosening, prosthesis revision, fixation, osteosynthesis, complication, ambulate, quality of life