Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06483256

Evaluation of Clinical and Radiographic Findings in Patients Treated Surgically for Biceps Long Head Injury

Led by Istituto Ortopedico Rizzoli · Updated on 2025-01-07

30

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an interventional, single-center study with clinical and radiographic evaluation, at follow-up of at least 2 years, of patients treated surgically with arthroscopy-assisted distal biceps tendon repair at the Rizzoli Orthopaedic Institute. The study consists of 2 phases (Identification of includable patients, Follow-up visit: * identification by trained medical staff of subjects who meet the study inclusion criteria * Patients, after signing informed consent, will be evaluated clinically and radiographically by radiography in lateral and anteroposterior projection at the follow-up visit by specialized medical personnel. A clinical examination will be performed, with subjective and objective evaluation questionnaires administered, and a strength assessment of the operated limb and contralateral limb will be performed using specific dynamometers on the same date as the radiography is performed at the Rizzoli Orthopedic Institute. The radiographic study with standard projections (AP and LL) is used to evaluate any signs of anchor loosening and/or presence of heterotopic ossifications (which can limit movement and represent one of the main complications). Study-specific radiographs will be performed on the same day as the outpatient clinical evaluation in consultation with the Radiology Service Manager.

CONDITIONS

Official Title

Evaluation of Clinical and Radiographic Findings in Patients Treated Surgically for Biceps Long Head Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of distal biceps tendon repair surgery
  • Surgery performed within 30 days of the injury
  • Patients treated surgically for distal biceps tendon injury by arthroscopy-assisted technique at the Shoulder-Elbow Department of the Rizzoli Orthopedic Institute from January 01, 2017 to December 31, 2022
Not Eligible

You will not qualify if you...

  • Younger than 18 years old at the time of surgery
  • Patients with non-surgery-related problems in the operated limb after surgery, such as fractures or new tendon injuries
  • Patients treated with different surgical techniques for distal biceps tendon injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Bologna, Italy, 40136

Actively Recruiting

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Research Team

E

Enrico Guerra, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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