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

Recruiting now · Not applicable

Conditions studied: Bicep Tendon Rupture

In brief

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 facts

Study ID

NCT06483256

Run by

Istituto Ortopedico Rizzoli

People needed

30

Starts

2024-11-13

Expected to finish

2026-12-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 at the time of distal biceps tendon repair surgery
• Surgery performed within 30 days of 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.

You may not qualify if…

• < 18 years old at the time of surgery
• Patients who have presented non-surgery-related problems to the operated limb in the years following surgery such as fractures or subsequent episodes of tendon injury.
• Patients treated for distal biceps tendon injury by different surgical techniques

Where it is running

• Istituto Ortopedico Rizzoli — Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

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