Evaluation of Long-term Clinical and Radiographic Outcomes of Radio-capitellar Prostheses

Not Applicable

Completed

• Conditions: Radiocapitellar Dislocation

• Registration Number: NCT05011578
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-18
• Study Start: 2022-12-15
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. ≥ 18 years of age at the time of radial capitate implantation surgery
2. Males and Females
3. 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

1. < 18 years old at the time of surgery
2. Patients treated with radial capitellum prosthesis implantation in fracture outcomes (e.g., secondary instability)
3. Patients who at the time of telephone contact have contraindications to the execution of radiographic examination
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mayo elbow performance score (MEPS):	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 Outcome Measures

Name	Time	Method
Broberg - Morrey Score	At least 10 years after radiocapitellar prosthesis surgical treatment	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.
Radiographic assesment (RX)	At least 10 years after radiocapitellar prosthesis surgical treatment	Radiographic assessment is useful to document re-ruptures, mobilizations and calcifications of the interested site
Treatment opinion post- surgery	At least 10 years after radiocapitellar prosthesis surgical treatment	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".
Short Form-12 (SF-12):	At least 10 years after radiocapitellar prosthesis surgical treatment	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy