Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06483256

Evaluation of Clinical and Radiographic Outcomes in Patients Surgically Treated for Distal Biceps Tendon 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

Researchers are evaluating clinical and radiographic outcomes in patients who underwent arthroscopy-assisted distal biceps tendon repair surgery. This single-center interventional study at the Rizzoli Orthopaedic Institute focuses on patients with bicep tendon rupture, followed for at least two years after surgery to assess recovery and complications. The study includes two phases: identifying eligible patients and conducting a follow-up visit. Eligible patients who consent will undergo clinical and radiographic evaluations using lateral and anteroposterior X-rays. The radiographic exams assess anchor loosening and heterotopic ossifications, which may restrict movement. Clinical examinations include subjective and objective questionnaires and strength testing of both the operated and opposite limbs using specialized dynamometers. Participants will have radiographic studies and clinical evaluations performed on the same day by specialized medical staff. Researchers will monitor outcomes like the Mayo elbow performance score measured from baseline post-surgery and observe any complications such as heterotopic ossifications. The study aims to provide a thorough assessment of surgical repair durability and functional recovery over a minimum two-year follow-up period.

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

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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Published Research Related To This Trial

Evaluation of Clinical and Radiographic Outcomes in Patients Surgically Treated for Distal Biceps Tendon Injury | DecenTrialz