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

NCT06483256 | Recruiting

• 1 other identifier: Artro-Bic
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bicep Tendon Rupture

Outcome Measures

Primary Outcomes (1)

• Mayo elbow performance score

  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.

  baseline (post surgery)

Secondary Outcomes (5)

• Disabilities of arm, shoulder and hand score

  baseline (post surgery)

• force evaluations with dynamometers

  baseline (post surgery)

• complications and reinterventions

  baseline (post surgery)

• patient satisfaction

  baseline (post surgery)

• radiography

  baseline (post surgery)

Study Arms (1)

radiographic control

OTHER

Standard AP and LL X-Rays of the affected elbow

Diagnostic Test: radiographic control

Interventions

radiographic control DIAGNOSTIC_TEST

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).

radiographic control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

RECRUITING

Related Publications (2)

• Srinivasan RC, Pederson WC, Morrey BF. Distal Biceps Tendon Repair and Reconstruction. J Hand Surg Am. 2020 Jan;45(1):48-56. doi: 10.1016/j.jhsa.2019.09.014.

  PMID: 31901332 BACKGROUND

• Schmidt CC, Madonna TJ, Vaudreuil N, Brown BT, Liu SY, Delserro S, Smolinski MP, Styron J, Smolinski PJ, Miller MC. The effect of tendon rotation on distal biceps repair. JSES Open Access. 2019 Sep 11;3(3):225-231. doi: 10.1016/j.jses.2019.06.001. eCollection 2019 Oct.

  PMID: 31709367 BACKGROUND

Central Study Contacts

Enrico Guerra, MD

CONTACT

0516366; enrico.guerra@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: November 13, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)