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

NCT05011578 | Completed

• 1 other identifier: Rad-Hop
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiocapitellar Dislocation

Keywords

radio-capitellar fracture; interventional study; Radiographic assessment; radio-capitellar prosthetic arthroplasty; long term clinical results; long term radiographic results; radio-capitellar prosthesis; radiographic results; clinical results

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Broberg - Morrey Score

  At least 10 years after radiocapitellar prosthesis surgical treatment

• Short Form-12 (SF-12):

  At least 10 years after radiocapitellar prosthesis surgical treatment

• Treatment opinion post- surgery

  At least 10 years after radiocapitellar prosthesis surgical treatment

• Radiographic assesment (RX)

  At least 10 years after radiocapitellar prosthesis surgical treatment

Study Arms (1)

clinical and radiographic findings after surgical treatment for radiocapitellar fracture

EXPERIMENTAL

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

Interventions

Radiographic assessment RADIATION

Radiographic assessment after at least 10 years after radiocapitellar surgical treatment

clinical and radiographic findings after surgical treatment for radiocapitellar fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (5)

• 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.

  PMID: 27053580 BACKGROUND

• 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.

  PMID: 7240327 BACKGROUND

• 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.

  PMID: 29332663 BACKGROUND

• 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.

  PMID: 11231669 BACKGROUND

• 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.

  PMID: 23827844 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 18, 2021
• Study Start: December 15, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

IT (1)