Evaluation of Long-term Clinical and Radiographic Outcomes of Radio-capitellar Prostheses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiocapitellar Dislocation
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Mayo elbow performance score (MEPS):
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 18 years of age at the time of radial capitate implantation surgery
- •Males and Females
- •Patients surgically treated for radial capitellum fracture undergoing prosthetic replacement with smooth-stemmed modular metal radial capitellum prosthesis at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute from 2003 to 2011.
Exclusion Criteria
- •\< 18 years old at the time of surgery
- •Patients treated with radial capitellum prosthesis implantation in fracture outcomes (e.g., secondary instability)
- •Patients who at the time of telephone contact have contraindications to the execution of radiographic examination
- •All available patients will be invited to perform the clinical examination and radiographic examination. If some patients are unable to undergo radiography due to possible contraindications, they will still be seen to collect the primary clinical outcome.
Outcomes
Primary Outcomes
Mayo elbow performance score (MEPS):
Time Frame: At least 10 years after radiocapitellar prosthesis surgical treatment
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.
Secondary Outcomes
- Broberg - Morrey Score(At least 10 years after radiocapitellar prosthesis surgical treatment)
- Radiographic assesment (RX)(At least 10 years after radiocapitellar prosthesis surgical treatment)
- Treatment opinion post- surgery(At least 10 years after radiocapitellar prosthesis surgical treatment)
- Short Form-12 (SF-12):(At least 10 years after radiocapitellar prosthesis surgical treatment)