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.

Study Overview

• Status: Completed
• Conditions: Radiocapitellar Dislocation
• Intervention / Treatment: Radiation: Radiographic assessment

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: clinical and radiographic findings after surgical treatment for radiocapitellar fracture; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At least 10 years after radiocapitellar prosthesis surgical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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".	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	At least 10 years after radiocapitellar prosthesis surgical treatment

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Fowler JR, Goitz RJ. Radial head fractures: indications and outcomes for radial head arthroplasty. Orthop Clin North Am. 2013 Jul;44(3):425-31, x. doi: 10.1016/j.ocl.2013.03.013. Epub 2013 Apr 17.
• Morrey BF, Askew LJ, Chao EY. A biomechanical study of normal functional elbow motion. J Bone Joint Surg Am. 1981 Jul;63(6):872-7.
• Marsh JP, Grewal R, Faber KJ, Drosdowech DS, Athwal GS, King GJ. Radial Head Fractures Treated with Modular Metallic Radial Head Replacement: Outcomes at a Mean Follow-up of Eight Years. J Bone Joint Surg Am. 2016 Apr 6;98(7):527-35. doi: 10.2106/JBJS.15.00128.
• Lott A, Broder K, Goch A, Konda SR, Egol KA. Results after radial head arthroplasty in unstable fractures. J Shoulder Elbow Surg. 2018 Feb;27(2):270-275. doi: 10.1016/j.jse.2017.10.011.
• Harrington IJ, Sekyi-Otu A, Barrington TW, Evans DC, Tuli V. The functional outcome with metallic radial head implants in the treatment of unstable elbow fractures: a long-term review. J Trauma. 2001 Jan;50(1):46-52. doi: 10.1097/00005373-200101000-00009.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: interventional study; radio-capitellar fracture; Radiographic assessment; radio-capitellar prosthetic arthroplasty; long term clinical results; long term radiographic results; radio-capitellar prosthesis; radiographic results; clinical results
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: Rad-Hop

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No