Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-21
Brief Title:
Evaluation of Clinical and Radiographic Findings in Patients Treated Surgically for Biceps Long Head Injury
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Evaluation of Clinical and Radiographic Findings in Patients Treated Surgically for Biceps Long Head Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Artro-Bic
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 andor 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
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 andor 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None