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

Study acronym: Artro-Bic
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 22, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Jun 2025 to Jun 2026
    • Study completion date: Jun 2025 to Dec 2026
    • Site details revised
    • Publications: details revised at 2 of 2 entries
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 15, 2024 to Nov 13, 2024
    • Publications: details revised at 2 of 2 entries
    v4
  3. Minor Start date: Oct 2024 to Oct 15, 2024
    • Study description expanded, about 183 words
    v3
  4. Notable Start date: Jul 2024 to Oct 2024v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06483256
Lead Sponsor Istituto Ortopedico Rizzoli
Conditions
(from sponsor)
Bicep Tendon Rupture
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov