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Completed

NCT Number: NCT05011578

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

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.

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Key information

Conditions

Radiocapitellar Dislocation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiographic assessment

Radiation

Radiographic assessment after at least 10 years after radiocapitellar surgical treatment

Primary outcomes

  1. 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

  1. Broberg - Morrey Score

    Time frame: 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.

  2. Short Form-12 (SF-12):

    Time frame: 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.

  3. Treatment opinion post- surgery

    Time frame: 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".

  4. Radiographic assesment (RX)

    Time frame: At least 10 years after radiocapitellar prosthesis surgical treatment

    Radiographic assessment is useful to document re-ruptures, mobilizations and calcifications of the interested site

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2021
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.