Clinical trial NCT05011578: Evaluation of Long-term Clinical and Radiographic Outcomes of Radio-capitellar Prostheses
Official title: Evaluation of Long-term Clinical and Radiographic Outcomes of Radio-capitellar Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mayo elbow performance score (MEPS):
timeFrame: At least 10 years after radiocapitellar prosthesis surgical treatment
Secondary outcomes:
measure: Broberg - Morrey Score
timeFrame: At least 10 years after radiocapitellar prosthesis surgical treatment
measure: Short Form-12 (SF-12):
timeFrame: At least 10 years after radiocapitellar prosthesis surgical treatment
measure: Treatment opinion post- surgery
timeFrame: At least 10 years after radiocapitellar prosthesis surgical treatment
measure: Radiographic assesment (RX)
timeFrame: At least 10 years after radiocapitellar prosthesis surgical treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.