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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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.

Eligibility

Primary outcome measure(s)

• Mayo elbow performance score — baseline (post surgery)
  It is currently considered the gold standard for objective measurement of elbow performance because of the immediacy of the results and its practicality of use. It assesses the presence of pain with a score from 0 to 45, Range of Motion with a score from 0 to 20, elbow stability with a score from 0 to 10, and the ability to perform 5 daily activities (combing, eating, personal hygiene, dressing, and putting on shoes) to each of which 5 points are assigned. It gives a result from 0 to 100 where results above 90 are defined as excellent, results between 75 and 89 are defined as good, between 60 and 74 are defined as sufficient and below 59 as poor.

Trial sites (1)

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