Evaluation of Clinical and Radiographic Findings in Patients Treated Surgically for Biceps Long Head Injury
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bicep Tendon Rupture
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mayo elbow performance score
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •\< 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
Outcomes
Primary Outcomes
Mayo elbow performance score
Time Frame: 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.
Secondary Outcomes
- complications and reinterventions(baseline (post surgery))
- radiography(baseline (post surgery))
- force evaluations with dynamometers(baseline (post surgery))
- patient satisfaction(baseline (post surgery))
- Disabilities of arm, shoulder and hand score(baseline (post surgery))