Evaluation of conservative treatment outcomes for distal biceps tendon injuries
Is Conservative Treatment Still an Option for Distal Biceps Tendon Lesions? Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions at 1 Year Minimum Follow-up
This study is testing how well non-surgical treatments work for people with complete distal biceps tendon injuries by looking at their recovery and strength over at least a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06602414 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical outcomes of patients who have undergone conservative treatment for complete acute distal biceps tendon ruptures. Participants will be assessed using clinical scores such as MEPS, DASH, and SF-12, along with strength and fatigue evaluations using dynamometers for elbow flexion and forearm supination. The results from the affected arm will be compared to the unaffected arm to determine the effectiveness of the conservative treatment over a minimum follow-up period of one year.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a complete acute distal biceps tendon rupture and were treated conservatively.
Not a fit: Patients under 18 years old, those with contraindications to strength evaluation, or those who have had surgical treatment for their injury will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of conservative treatment for distal biceps tendon ruptures, potentially guiding treatment decisions for similar injuries.
How similar studies have performed: While there may be limited data on conservative treatment outcomes for this specific injury, similar studies on tendon injuries have shown varying degrees of success with conservative management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than or equal to 18 years old at time of injury * Complete acute distal biceps tendon rupture diagnosed and evaluated at IRCCS Istituto ortopedico Rizzoli between 2000 and 2024 treated conservatively Exclusion Criteria: * \< 18 years at time of injury * Patients who present controindications to the strenght evaluation * Patients who have developed other non correlated injuries to the affected arm (e.g. fractures or tendon injuries) * Patients treated surgically for distal biceps tendon rupture
Where this trial is running
Bologna, BO
- Istituto Ortopedico Rizzoli — Bologna, Bo, Italy (Recruiting)
Study contacts
- Study coordinator: Federico Coliva, MD
- Email: federico.coliva@ior.it
- Phone: +393347781701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.