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RECRUITING
NCT06483256
NA

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

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-13

Completion Date

2025-06

Last Updated

2025-01-07

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

radiographic control

Radiographic study with standard projections (AP and LL) is used to assess any signs of anchor loosening and/or presence of heterotopic ossifications (which can restrict movement and is one of the main complications).

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Bologna, Italy