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

NCT ID: NCT06483256

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2025-06-30

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.

Conditions

Bicep Tendon Rupture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

radiographic control

Standard AP and LL X-Rays of the affected elbow

Group Type: OTHER

radiographic control

Intervention Type: 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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Enrico Guerra

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istituto Ortopedico Rizzoli

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Enrico Guerra, MD

Role: CONTACT

enrico.guerra@ior.it

0516366 ext. 39

Facility Contacts

Enrico Guerra, MD

Role: primary

enrico.guerra@ior.it

6366567

Roberta Licciardi, MSc

Role: backup

roberta.licciardi@ior.it

6366567 ext. 051

References

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.

Reference Type: BACKGROUND

PMID: 31901332 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31709367 (View on PubMed)

Other Identifiers

Artro-Bic

Identifier Type: -

Identifier Source: org_study_id