An interventional study of Radiographic assessment in Radiocapitellar Dislocation, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
The aim of this study is to collect clinical and radiographic data from the case histories of patients surgically treated for radio-capitellar fracture and undergoing prosthetic replacement with a modular metal radio-capitellar prosthesis with smooth stem at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute, in order to evaluate the clinical and radiographic results at least 10 years after surgery.
The aim of the study is to collect clinical and radiographic data from the case history of patients (about 30 cases) surgically treated from 2003 to 2011 at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute for radio-capitellar fracture with prosthetic replacement with a modular metal radio-capitellar prosthesis with smooth stem in order to evaluate the clinical and radiographic results at least 10 years after treatment. Patients will be contacted to perform a clinical examination and radiographic control at the Rizzoli Orthopaedic Institute.
This is an interventional study with clinical and radiographic evaluation, at FU of at least 10 years, of patients treated surgically with prosthetic replacement for radio-capitellar fracture at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute.
190 studies on the registry are indexed under Joint Dislocations; 39 are open to participants now.
This study's enrollment of 35 is below the median of 53 across 120 interventional studies indexed under Joint Dislocations.
Browse Joint Dislocations studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
30 patients will be included in a interventional study for an evaluation of the clinical and radiographic finding after at least 10 years after radiocapitellar surgery
Radiation: Radiographic assessment
Radiographic assessment after at least 10 years after radiocapitellar surgical treatment
Mayo elbow performance score (MEPS):
MEPS score assesses the presence of pain with a score of 0 to 45, Range of Motion with a score of 0 to 20, elbow stability with a score of 0 to 10, and the ability to perform 5 activities of daily living (combing, eating, personal hygiene, dressing, and putting on shoes) to each of which 5 points are assigned. It provides a result from 0 to 100 where results above 90 are defined as excellent, results between 75 and 89 are defined as good, between 60 and 74 are defined as sufficient and below 59 as poor.
Time frame: At least 10 years after radiocapitellar prosthesis surgical treatment
Broberg - Morrey Score
The Broberg and Morrey assessment system is a 100-point system that summarizes data from the medical record, personal interview, and biomechanics laboratory examination. It consists of four sections: motion (40 points), strength (20 points), stability (5 points), and pain (35 points). In the final evaluation 95-100 points indicate an excellent result; 80-94 points, a good result; 60-79 points, a fair result; ≤60 points, a poor result. The result can be considered satisfactory if the outcome is rated as good or excellent and unsatisfactory if it is fair or poor.
Time frame: At least 10 years after radiocapitellar prosthesis surgical treatment
Short Form-12 (SF-12):
SF-12 serves as a generic indicator of quality of life and assesses the individual's subjective perception of health, understood as biopsychosocial well-being. Through 12 of the 36 questions of the original questionnaire, the SF-12 investigates 8 different aspects related to health status: physical activity, role limitations due to physical health, emotional state, physical pain, perception of general health status, vitality, social activities and mental health; the synthesis of the total scores allows to build two synthetic indices, a physical health index (PCS-12) and a mental health index (MCS-12). The lower the score of the two indices, indicatively below 20 points, the greater the level of disability.
Time frame: At least 10 years after radiocapitellar prosthesis surgical treatment
Treatment opinion post- surgery
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".
Time frame: At least 10 years after radiocapitellar prosthesis surgical treatment
Radiographic assesment (RX)
Radiographic assessment is useful to document re-ruptures, mobilizations and calcifications of the interested site
Time frame: At least 10 years after radiocapitellar prosthesis surgical treatment
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli