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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Radiocapitellar Dislocation

Treatments: Radiation: Radiographic assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05011578

Rad-Hop

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

clinical and radiographic findings after surgical treatment for radiocapitellar fracture

Experimental group

Description:

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

Treatment:

Radiation: Radiographic assessment