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

Recruiting

• Conditions: Periprosthetic Fractures; Peri-implant Fracture; Peri-implant Fracture of the Upper or Lower Limb; Periprosthetic Fracture of the Upper or Lower Limb

• Registration Number: NCT04663893
• Lead Sponsor: Hospital Clínico Universitario de Valladolid

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.

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 Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-11
• Study Start: 2021-01-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-16
• Last Update Posted: 2022-02-01
• Primary Completion: 2022-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Up to 12 months	Rate of mortality at anytime from fracture diagnose up to 12 months
Fracture classification	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
Treatment	Post-operatively (Day +1)	Number of patients treated with fixation or revision and fixation or implant removal

Secondary Outcome Measures

Name	Time	Method
Bone protector treatment	Up to 12 months	Is the patient under treatment with vitamine D, calcium, bone formation, bone modeling?
Gait	Up to 12 months	FFN-MCD mobility scale (Fragility Fracture Network-Minimum Common Dataset). 1-5: 1=independent mobility, 5=No functional mobility
Health related quality of life	Up to 12 months	EuroQuality of Life 5Dimensions 5Leves (EQ5D5L)
Mental situation	Up to 12 months	Pfeiffer test
Fracture healing	Up to 12 months	Rate of bone union on X-rays
Dependency	Up to 12 months	Clinical frailty scale (1-9) 1=very fit, 9=terminally ill
Life style change	Up to 12 months	Need to change place of living because of the fracture or its sequels.
Medical or Surgical complications	Up to 12 months	in need of at least one in-hospital night.

Trial Locations

Locations (7)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario Vall d´Hebrón; 🇪🇸 Barcelona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Althaia, Xarxa Assistencial Universitària de Manresa; 🇪🇸 Barcelona, Spain

Mutua Universitaria de Tarrasa; 🇪🇸 Barcelona, Spain

Hospital de Jove; 🇪🇸 Gijón, Spain